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60 Graft-Versus-Host Disease Trials Near You
Power is an online platform that helps thousands of Graft-Versus-Host Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBelumosudil for Bronchiolitis Obliterans Syndrome
Ann Arbor, Michigan
The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).
The name of the study drugs involved in this study are:
* Belumosudil (an immunotherapy)
* Fluticasone (an intranasal corticosteroid)
* Azithromycin (an antibiotic)
* Montelukast (a leukotriene receptor antagonist)
* Prednisone (a corticosteroid)
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Prior BOS Therapy, HIV, Hepatitis B/C, Others
Must Not Be Taking:Investigational Immunosuppressants
45 Participants Needed
ATG + PTCy for Graft-versus-Host Disease Prophylaxis
London, Ontario
A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:16 - 70
Key Eligibility Criteria
Disqualifiers:HIV, Pregnancy, Infection, Others
Must Not Be Taking:T-cell Antibody
80 Participants Needed
Abatacept for Graft-versus-Host Disease Prevention
Chicago, Illinois
This trial will see if extended abatacept administration (combined with a standard regimen of tacrolimus and mycophenolate mofetil) will prevent acute and chronic graft-versus-host disease (GVHD) in children and adolescents receiving unrelated donor (URD) hematopoietic stem cell transplantation (HSCT), without compromising their engraftment or reconstitution of protective immunity to infection.
The study will enroll 30 pediatric patients with serious non-malignant hematologic diseases (NMHD) undergoing URD HSCT. The trial will include patients with 7/8 donors and those with 8/8 (matched) donors. All participants will receive 8 doses of abatacept. Recruitment is expected to last for about 2 years and participants will be followed for up to 3 years.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:< 20
Key Eligibility Criteria
Disqualifiers:HLA Matched Donor, Pulmonary Dysfunction, Renal Dysfunction, Severe Cardiac Dysfunction, Others
30 Participants Needed
Stem Cell Transplant + Chemotherapy for Leukemia and Lymphoma
Buffalo, New York
This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving cyclophosphamide after the transplant may stop this from happening.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Myelofibrosis, HLA Antibodies, HIV, Others
35 Participants Needed
Fostamatinib for Post-Transplant Cytopenias
Bethesda, Maryland
Background:
People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Cytopenia can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant.
Objective:
To test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant.
Eligibility:
People aged 18 to 75 years who have cytopenia after a blood stem cell transplant.
Design:
Participants will be screened. They will have a physical exam. They will have blood, urine, and stool tests.
Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a day for 12 weeks.
Participants will have a medical assessment every 2 weeks; their vital signs will be checked, and they will have blood and stool tests. Participants must come to the NIH clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or telehealth; the blood and stool tests can be sent to the researchers from a local lab.
After 4 weeks, some participants may begin taking a higher dose of the drug.
Participants will return for a final medical assessment 2 weeks after they finish taking the drug.
Participants who complete this study and show evidence that fostamatinib has increased their blood cell counts may enroll in an extension study to continue taking fostamatinib.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Illness, Uncontrolled Hypertension, Others
Must Not Be Taking:Fostamatinib, Cytokine-targeting Biologics
20 Participants Needed
Pacritinib for Chronic Graft-versus-Host Disease
Bethesda, Maryland
This trial tests pacritinib, a capsule taken by mouth, in adults with moderate or severe chronic graft-versus-host disease (cGVHD) that hasn't responded to other treatments. Pacritinib helps by blocking proteins that cause inflammation and immune issues. Participants will take the drug regularly and have periodic check-ups over an extended period.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Active HIV, Hepatitis B, Hepatitis C, Others
Must Not Be Taking:Ruxolitinib, Ibrutinib, CYP3A4 Inducers
50 Participants Needed
Ibrutinib for Chronic Graft-versus-Host Disease
Bethesda, Maryland
This trial is testing ibrutinib, a pill that blocks a protein causing harmful immune reactions, in adults with newly diagnosed moderate or severe chronic graft-versus-host disease (cGVHD). The goal is to see if this drug can help control the disease by reducing the immune system's attack on the body. Ibrutinib was the first agent approved by the U.S. Food and Drug Administration for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Malignant Disease, Cardiac Issues, Infections, Others
Must Be Taking:Immunosuppressive Medications
10 Participants Needed
This trial tests if using low dose radiation and certain drugs can help patients with beta-thalassemia or sickle cell disease better accept donor stem cells. The treatment aims to suppress the immune system to reduce rejection of the new cells.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:4 - 80
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infections, Major Illness, Pregnancy, Others
56 Participants Needed
Alvelestat for Bronchiolitis Obliterans Syndrome
Bethesda, Maryland
Background:
Bronchiolitis obliterans syndrome (BOS) is a complication people can experience after hematopoietic stem cell transplant. It usually affects people with chronic graft versus host disease (cGVHD). This occurs when donor stem cells attack the cells of the person who received them. BOS reduces airflow and oxygen levels in the body. It may be caused by neutrophil elastase in the body. Researchers believe the new drug alvelestat (MPH966) may help.
Objectives:
To test the safety of alvelestat (MPH966) and see what dose best inhibits neutrophil elastase in people with BOS after a stem cell transplant. To study how well the best dose improves lung function in those people.
Eligibility:
Adults 18 and older who have had a hematopoietic stem cell transplant and have cGVHD and BOS.
Design:
Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have lung function and heart function tests. They will have computed tomography scans of the chest.
Study part 1: Participants will take the starting dose of the study drug by mouth twice a day for 14 days. This is 1 cycle. They will get different doses, for up to 4 cycles.
Study part 2: Participants will take the study drug twice a day by mouth at the dose set in part 1, for up to 12 months.
Participants will keep medicine diaries.
Participants will have several study visits. These may include:
Repeats of the screening tests.
Bronchoscopy with bronchoalveolar lavage.
Sputum samples taken.
6-minute walking test.
cGVHD assessment and answer questions.
Participants will be contacted after the study for up to 24 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Significant Alcohol Use, Others
Must Be Taking:Inhaled Steroids, Montelukast
34 Participants Needed
Low-Dose Cyclophosphamide for Blood Cancers
Bethesda, Maryland
Background:
Stem cell or bone marrow transplants can cure or control blood cancers. Sometimes the donor cells see the recipient's body as foreign. This can cause complications. A high dose of the drug cyclophosphamide (PTCy) can help reduce these risks. Researchers want to see if a lower dose of PTCy can have the same benefits. Based on encouraging results from the first part of the study, researchers now are investigating whether a lower dose of PTCy can allow other immunosuppression to be decreased.
Objective:
To see if a lower dose of PTCy and now also shorter duration of another immunosuppressant called mycophenolate mofetil will help people with blood cancers have a more successful transplant and fewer side effects.
Eligibility:
People ages 15-65 with leukemia, lymphoma, or multiple myeloma that is not curable with standard therapy and is at high risk of returning without transplant, and their healthy adult relatives
Design:
Transplant participants will be screened with:
Blood, urine, breathing, and heart tests
Scans
Chest x-ray
Bone marrow samples: A needle inserted into the participant s pelvis will remove marrow and a bone fragment.
Transplant recipients will stay at the hospital and be prepped with chemotherapy over 6 days for the transplant. They will get stem cells through a catheter in the chest or neck. They will get the cyclophosphamide chemotherapy. They will stay in the hospital about 4 more weeks. They will have blood transfusions. They will have frequent blood tests and 2 bone marrow samples within 1 year after the transplant.
Donor participants will be screened with:
Blood, urine, and heart tests
Chest x-ray
Scans
Donor participants will have bone marrow taken from their pelvis or stem cells taken from their blood. For the blood donation, blood will be taken from a vein in one arm, move through a machine to remove white blood cells, and be returned through a vein in the other arm.
Participation will last up to 5 years....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Uncontrolled Illness, Active Non-hematologic Cancer, Others
Must Not Be Taking:Investigational Agents
400 Participants Needed
Fostamatinib for Immune Thrombocytopenia (ITP)
Bethesda, Maryland
Background:
People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Up to 20% of people who have blood stem cell transplants develop cytopenias, which can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant.
Objective:
To evaluate the long-term effects of a study drug (fostamatinib) in people with cytopenia after a blood stem cell transplant.
Eligibility:
People who responded well to fostamatinib in an earlier study.
Design:
Participants will be screened. They will have a physical exam and blood tests.
Fostamatinib is an oral tablet taken by mouth. Participants will take the pills at the same dose and frequency as they did during the previous study. They will take the pills for up to 21 months. The dosage of the drug may be reduced over time if their blood cell levels are stable.
Participants will have a medical assessment every month. This can be with their local doctor or at the NIH clinic.
Participants will have blood tests every 3 months.
Participants will have a follow-up visit after they stop taking the drug. Their vital signs will be taken, and they will have blood drawn. They will answer questions about their health.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Illness, Uncontrolled Hypertension, Others
Must Be Taking:Fostamatinib
20 Participants Needed
Ruxolitinib + Panobinostat for Myelofibrosis
Toronto, Ontario
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:1 - 100
Key Eligibility Criteria
Disqualifiers:Pregnancy, Nursing, Approved Indication, Others
Must Be Taking:Ruxolitinib, Panobinostat
279 Participants Needed
Stem Cell Transplant for Sickle Cell Anemia
Bethesda, Maryland
Background:
Sickle cell disease can often be treated with blood stem cell transplants. But for some people the disease returns. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.
Objective:
To cure people s sickle cell disease by giving a second treatment that makes more room in their bone marrow for donor cells.
Eligibility:
People ages 4 and older with sickle cell disease who had a transplant but the disease returned, and their donor relatives. Donors can be 2 years of age or older.
Design:
Participants will be screened with medical history, physical exam, and blood tests.
Recipients will also be screened with heart and breathing tests, x-rays, a bone marrow sample, and teeth and eye exams. They must have a caregiver.
Donors will have 7-8 visits. They will take a drug for 5-6 days to prepare them for the donation. For the donation, blood is taken from a vein in the arm or groin. The stem cells are collected. The rest of the blood is returned. This may be repeated.
Recipients will get a long IV line in their arm or chest for about 1-2 months. They will take drugs to help their body accept the donor cells. They will get the donor cells and red blood cell transfusions through the line. They will stay in the hospital about 30 days after the transfusion of donor cells.
In first 3 months after the infusion, recipients will have many visits. Then they will have visits every 6 months to 1 year for 5 years. During those visits they will repeat some of the screening tests....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:2 - 80
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infections, Major Organ Failure, Pregnancy, Secondary Malignancies, Others
32 Participants Needed
Reduced-Dose Cyclophosphamide for Blood Cancer
Bethesda, Maryland
This trial is testing if a lower dose of cyclophosphamide after a bone marrow transplant can help adults with difficult-to-treat blood cancers. The aim is to prevent complications from donor cells attacking the body while reducing side effects. The study focuses on patients who are older, less fit, or have not had success with other treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12 - 85
Key Eligibility Criteria
Disqualifiers:Uncontrolled Illness, Active Non-hematopoietic Cancer, Others
Must Not Be Taking:Investigational Agents
320 Participants Needed
Donor Lymphocyte Infusion for Blood Cancers
Bethesda, Maryland
This trial is testing if giving white blood cells from a donor to patients with high-risk blood cancers can reduce the risk of the cancer coming back. The goal is to see if this approach helps fight off remaining cancer cells and prevents relapse.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Active Non-hematopoietic Malignancy, Others
Must Not Be Taking:Investigational Agents
430 Participants Needed
Stem Cell Transplant for SCID
Bethesda, Maryland
Background:
Severe combined immune deficiency (SCID) is a group of conditions where the immune system does not work properly. The only cure for most SCIDs is a stem cell transplant (getting cells from a donor). These transplants can have serious complications. Before the transplant, people often get high doses of drugs and radiation to prepare the body to accept the cells from the donor. Researchers want to see if low doses of drugs alone without radiation work just as well as low doses of drugs with radiation for SCID patients getting stem cell transplants.
Objective:
To test a set of drugs with or without radiation given before a stem cell transplant.
Eligibility:
People ages 3-40 who have SCID and who have a stem cell donor - either related or unrelated.
Design:
Participants will be admitted to the hospital 10 days before transplant. They will undergo:
medical history
medication review
physical exam
blood and urine tests (may include a 24-hour urine collection)
heart, lung, and breathing tests
imaging scans
bone marrow sample
nutrition assessment
dental exam
eye exam
meeting with a social worker.
Participants will get a plastic port called a central line. It is a hollow tube that is placed in the upper chest. It will be used to give medicines and take blood.
All participants will take chemotherapy drugs. Some will get radiation.
Participants will have a stem cell transplant. They will get the cells as an infusion through their central line. They will stay in the hospital for 30 days after transplant.
Participants must stay within 1 hour of NIH for 3 months after transplant. During this time, they will have follow-up visits at NIH at least once a week. Then they will have follow-up visits once or twice a year for 5-6 years.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 1, 2
Age:3 - 40
Key Eligibility Criteria
Disqualifiers:ECOG Status 3+, Heart Failure, Liver Issues, Psychiatric Disorder, Seizure Disorder, Others
30 Participants Needed
Stem Cell Transplant for Sickle Cell Disease
Bethesda, Maryland
Background:
Peripheral blood stem cell transplantation procedures are used for people with sickle cell disease. Researchers want to improve the success and reduce the complications for these procedures. This might allow more people to have a transplant.
Objective:
To see if a new transplant regime is effective, safe and well tolerated in people with sickle cell disease.
Eligibility:
Adults at least 18 years old with sickle cell disease and certain complications.
A relative who is a half tissue match.
Design:
Participants will be screened with medical history, physical exam, and blood tests. Recipients will also have:
* Heart, lung, and mental health tests
* Chest x-rays
* Bone marrow taken from the pelvic bone
* Eyes and teeth checked
Recipients will have a large central line inserted into a vein for up to 6 months.
Donors will have their veins tested and have an IV inserted for 1 day or on rare occasions 2 days.
Donors will get a drug to activate bone marrow. It will be injected for about 6 days.
Donors will have at least 1 five-hour procedure where bone marrow stem cells will be collected. Blood will be taken from a vein in one arm or in rare cases from a groin vein and put through a machine. Some blood will be saved and the rest will be returned. Stem cells will be taken from the saved blood in a lab and frozen until ready to give to the recipient.
Recipients will have:
* Stems cells collected and frozen
* Hygiene lessons
* Bone density scans
* Low-dose radiation
* Drugs for their immune system
* Donor cells infused through their central line
* Transfusions
After about 30 days, recipients will leave the hospital. They must stay near NIH for 3 months after the transplant and have frequent visits. After returning home, they will have 8 visits over 5 years, then be contacted yearly.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 100
Key Eligibility Criteria
Disqualifiers:HLA-matched Donor, Infections, Pregnancy, Others
57 Participants Needed
Haploidentical Transplant for Chronic Granulomatous Disease
Bethesda, Maryland
Background:
CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used. Researchers want to see if they can lower the risks of using a mismatched donor.
Objectives:
To see if it is safe to use a related bone marrow donor who is only a partial match to a person with CGD. To see how well drugs given to a person before and after transplant help the body accept the transplant.
Eligibility:
People ages 4-65 with CGD for whom stem cell transplant may be a cure and who do not have a perfectly matched donor, related or unrelated.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Participants will be admitted to the hospital about 2 weeks before the transplant. They will have blood, urine, breathing, and heart tests. They may have CT and/or MRI scans. They will have a needle inserted into their hipbone to remove marrow. They will have dental, neurologic, and psychologic tests. They will have a central catheter placed: A line will be placed into a vein in their upper chest. They will get drugs, chemotherapy, and radiation to prepare for the transplant.
Participants will receive the donated cells through their catheter. The cells will be from one of their relatives.
Participants will stay in the hospital about 6 weeks after the transplant.
After they leave the hospital, participants will have to stay in the area with visits about 2 times a week for approximately 100 days post transplant. Then visits will be every 3 to 6 months for 2 years. Then visits will be once a year.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Age:4 - 65
Key Eligibility Criteria
Disqualifiers:Severe Colitis, Heart Failure, Psychiatric Disorders, Others
Must Not Be Taking:Anti-TNF, Anti-interleukin, Anti-integrin
4 Participants Needed
Cord Blood Transplant for Blood Cancers and Diseases
Bethesda, Maryland
Background:
- Cord blood transplants can treat cancers and other diseases in children and adults. The U.S. Food and Drug Administration (FDA) requires cord blood to be collected and stored under certain safety standards. However, most available cord blood units were collected before the FDA set these standards. These units may not meet FDA standards, but they do meet similar standards set and followed by the National Marrow Donor Program (NMDP). Cord blood units that do not meet the new FDA standards may be used for transplants only as part of a research study. Doctors want to allow people who need transplants to receive cord blood that meets NMDP standards but may not meet FDA standards.
Objectives:
- To allow selected cord blood units that do not meet current FDA standards to be used for transplant.
Eligibility:
- Individuals who need cord blood units for transplant, and who best match cord blood units that are not FDA-licensed.
Design:
Participants will provide consent to receive cord blood that meets NMDP standards but may not meet FDA standards.
Participants will remain on the study for observation for up to 1 year after transplant, or until they withdraw from the study for personal or medical reasons....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:4 - 99
Key Eligibility Criteria
Disqualifiers:Licensed CBUs, International Centers, Other IND Protocol, Others
500 Participants Needed
Stem Cell Transplant for Sickle Cell Anemia
Bethesda, Maryland
This trial tests a new bone marrow transplant method for adults with sickle cell disease and Beta-thalassemia. It uses stem cells from a half-matched family donor, low-dose radiation, and immunosuppressant drugs, but no chemotherapy. The goal is to reduce complications and improve outcomes for patients who lack fully matched donors.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:2 - 80
Key Eligibility Criteria
Disqualifiers:Pregnancy, Infections, Organ Failure, Others
Must Be Taking:Immunosuppressants
23 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
Steroid Tapering for Pediatric Graft-versus-Host Disease
Washington, District of Columbia
The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to steroids or the response does not last. In those cases, the GVHD can become dangerous and even life-threatening. Unfortunately, doctors cannot predict who will have a good response to treatment based on symptom severity or initial response to steroids. As a result, nearly all children who develop GVHD are treated with long courses of high dose steroids even though that means many patients receive more treatment than they probably need. Steroid treatment can cause short-term complications like infections, high blood sugar, high blood pressure, muscle weakness, depression, anxiety, and problems sleeping and long-term complications like bone damage, cataracts in the eyes, and decreased growth. The risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses.
The doctors conducting this research have developed a blood test (GVHD biomarkers) that predicts whether a patient will respond well to steroids. The study team found that children who have low GVHD biomarkers at the start of treatment and for the first two weeks of treatment have a very high response rate to steroids. In this study, the study team will monitor GVHD symptoms and biomarkers during treatment and taper steroids quickly in patients who have GVHD that is expected to respond very well to treatment. The study team will assess how many patients respond well to lower steroid dosing and what steroid complications develop. The study team will also use surveys to obtain the patient's own assessment of their quality of life (down to age 5 years).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:< 21
Key Eligibility Criteria
Disqualifiers:Uncontrolled Infection, Chronic GVHD, Others
Must Not Be Taking:Corticosteroids
50 Participants Needed
Cyclophosphamide + Ruxolitinib for Graft-versus-Host Disease Prophylaxis
Milwaukee, Wisconsin
This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:60+
Key Eligibility Criteria
Disqualifiers:Prior Allogeneic HCT, Liver Dysfunction, Renal Impairment, Cardiac Dysfunction, Others
56 Participants Needed
Cyclophosphamide for GVHD Prevention
Hershey, Pennsylvania
This Phase 2, single-arm, open-label study aims to evaluate the safety and efficacy of low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) in patients undergoing allogeneic stem cell transplantation following reduced-intensity or non-myeloablative conditioning. The study will focus on matched sibling, matched unrelated, and haploidentical peripheral blood stem cell donors. The primary endpoint is 1-year GVHD-Free Relapse-Free Survival (GRFS). The study seeks to determine if low-dose PTCy offers similar outcomes as higher doses, with potentially reduced toxicity.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Prior Transplant, CNS Involvement, Infections, HIV, Heart Issues, Others
Must Not Be Taking:Investigational Agents, Immunosuppressants
41 Participants Needed
Eye Complications for Cancer Therapy
Baltimore, Maryland
The purpose of this study is to collect data on patients seen at University of Maryland after undergoing cancer therapy. Previous medications, ocular history, medical history, clinical evaluations, surgical procedures and outcomes will be gathered on the patients who consent to participate. Potential subjects will be enrolled from the clinical practice of the investigator at the time of their eye examination visit. A standard of care exam will be performed pertinent to the reason for the visit. In addition to the standard of care exam, certain biological specimens (ocular surface wash, mucocellular material, corneal filaments, impression cytology, and/or blood) will be collected, stored, and analyzed to obtain immunologic, cellular, or molecular mechanistic insights into disease pathogenesis.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ocular Surgery, Cancer Therapy, Others
150 Participants Needed
Belumosudil for Chronic Graft-Versus-Host Disease
Baltimore, Maryland
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above.
The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Cancer Relapse, Severe Illness, Others
Must Be Taking:Glucocorticoids
36 Participants Needed
Prebiotic Supplement for Acute GVHD
Durham, North Carolina
The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two two parts. In phase 1, the best dose of GOS will be evaluated. In phase 2, using the best dose of GOS, participants will be randomized to receive GOS or a placebo (maltodextrin, a common food additive that is not known to affect the microbiome) so that the effect of GOS can be determined.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnant, Malabsorption, Grade 2 GI Symptoms, Others
Must Not Be Taking:Prebiotics, Probiotics, Herbal Supplements, Antibiotics
128 Participants Needed
Ruxolitinib + Fostamatinib for Chronic Graft-versus-Host Disease
Durham, North Carolina
This is an open-label phase I study of fostamatinib in combination with ruxolitinib for the treatment of chronic GvHD with a suboptimal response to corticosteroids. The primary objective is to identify a minimum safe and biologically effective dose of fostamatinib when combined with standard of care ruxolitinib for the treatment of steroid refractory and steroid dependent cGVHD. The secondary objective is to estimate the efficacy of the combination of ruxolitinib and fostamatinib for the treatment of steroid refractory and steroid dependent cGVHD.
The target enrollment is 24-30 subjects. The study will begin with an initial dose escalation cohort employing a modified 3+3 design to investigate up to three doses of fostamatinib. Using safety, efficacy, pharmacodynamic (PD), and pharmacokinetic data (PK), an interim assessment will be performed to determine two candidate doses of the biologically optimal dose to investigate further. A safety expansion cohort will be opened to backfill these two candidate doses up to a total 12 patients per dose, including those in the dose escalation cohort who received the candidate doses. Patients will then be randomized to one of these two candidate doses in the expansion. If there is an imbalance in the two expansion cohorts, the remaining patient slots after 1:1 randomization will be sequentially backfilled to a total of 12 patients per cohort. A final analysis of safety, efficacy, and PK/PD data in patients who received the two candidate doses will be conducted to determine a minimum safety and biologically effective dose, which will be the recommended phase II dose (RP2D).
The primary hypothesis is that Fostamatinib combined with ruxolitinib is a safe therapy for and has synergistic activity in cGvHD. The recommended phase II dose will be determined by the study investigators in collaboration with the sponsors. The decision to select the recommended phase II dose will occur only after all patients in the part 1 have completed at least 28 days of therapy. The decision will be based on the valuation of all relevant, available data, and not solely on dose-limiting toxicities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Relapsed Malignancy, Active Infection, Cardiovascular Disease, Others
Must Be Taking:Corticosteroids, Calcineurin Inhibitors
30 Participants Needed
Mesenchymal Stromal Cells for Dry Mouth
Madison, Wisconsin
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth.
Participants will:
* have bone marrow collected using a needle
* undergo a salivary gland ultrasound
* complete questionnaires
* receive an injection of the bone marrow cells into a salivary gland
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Diabetes, Malignancy, Transfusion Dependency, Others
Must Not Be Taking:Diuretics, Investigational Drugs
36 Participants Needed
Ruxolitinib for Graft-Versus-Host Disease Prevention
Saint Louis, Missouri
Allogeneic hematopoietic cell transplantation (HCT) is one of the only curative intent therapies available for hematologic malignancies. HLA-matched sibling donors have historically offered the best clinical results but are unavailable for the majority of patients, while most patients do have readily available haploidentical donors. One of the risks of a haploidentical HCT is graft vs. host disease (GVHD), but it is difficult to reduce the incidence of GVHD without compromising the graft vs. leukemia (GVL) effect.
The hypothesis of this study is that JAK inhibition with and without CTLA-4 Ig with haploidentical HCT may mitigate GVHD and cytokine release syndrome while retaining the GVL effect and improving engraftment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Prior Allogeneic Transplant, HIV, Hepatitis, Others
Must Be Taking:Tacrolimus, Mycophenolate Mofetil, Cyclophosphamide
41 Participants Needed
SYN-004 for Post-Bone Marrow Transplant Complications
Saint Louis, Missouri
Study Objectives:
1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP).
2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP.
3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP.
4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Allergies, Other Studies, Liver Issues, Others
Must Be Taking:Beta-lactam Antibiotics
36 Participants Needed
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Frequently Asked Questions
How much do Graft-Versus-Host Disease clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Graft-Versus-Host Disease clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Graft-Versus-Host Disease trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Graft-Versus-Host Disease is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Graft-Versus-Host Disease medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Graft-Versus-Host Disease clinical trials?
Most recently, we added Vorinostat for GVHD Prevention, Cyclophosphamide for GVHD Prevention and Fostamatinib for Immune Thrombocytopenia (ITP) to the Power online platform.
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