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GVHD Prophylaxis Regimens for Blood Cancer Stem Cell Transplant
Phase 2
Recruiting
Led By Masumi Ueda Oshima
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy
Mismatched for two HLA class I alleles, but matched for HLA-DRB1 and HLA-DQ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year post-hct
Awards & highlights
Study Summary
This trial is studying two different drug combinations to reduce the risk of a common but serious complication called "graft versus host disease" (GVHD) following a blood stem cell transplant from an unrelated donor to treat blood cancer.
Who is the study for?
Adults aged 18-50 with certain high-risk blood cancers treatable by stem cell transplant from an unrelated donor, but who can't handle high-dose transplants due to medical conditions or prior therapy. Specific criteria include having less than 5% marrow blasts for some leukemias and being in remission for others. Must not be pregnant, breastfeeding, have severe organ dysfunction or active infections unresponsive to treatment.Check my eligibility
What is being tested?
This phase II trial tests a lower dose of chemotherapy combined with a blood stem cell transplant from an unrelated donor to treat various blood cancers. It compares two drug combinations (CSP+SIR+MMF vs CSP+SIR+PTCy) aiming to reduce graft versus host disease risk after the transplant.See study design
What are the potential side effects?
Potential side effects may include immune system suppression leading to increased infection risk, liver and kidney function impairment, gastrointestinal issues like nausea and diarrhea, mouth sores, fatigue, and possible allergic reactions to the drugs used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Waldenstrom's macroglobulinemia and two treatments have not worked for me.
Select...
My donor and I mismatch for two HLA class I alleles but match for HLA-DRB1 and HLA-DQ.
Select...
I am 18-50 years old with a blood disease, at high risk due to my medical history.
Select...
My donor is a partial match for my transplant.
Select...
My donor is a match for HLA class I and may have up to two mismatches in DRB1 or DQB1.
Select...
My donor is not a full HLA match but matches at key HLA points.
Select...
My AML is in remission with less than 5% marrow blasts.
Select...
I have CML and either TKIs didn't work for me or I couldn't tolerate them.
Select...
My genetic match for the transplant is nearly perfect, with only one minor difference.
Select...
My donor and I do not have a two-allele mismatch.
Select...
I am between 18 and 50 years old with chronic lymphocytic leukemia.
Select...
My leukemia has less than 5% marrow blasts before transplant.
Select...
My stem cell donor will use G-CSF for stem cell collection.
Select...
My BPDCN is currently in complete remission.
Select...
My donor and I are a close match for bone marrow transplant.
Select...
My Hodgkin lymphoma did not respond to the first treatment I received.
Select...
I have an aggressive type of non-Hodgkin lymphoma and am not a candidate for certain stem cell transplants.
Select...
I am over 50 and have a blood cancer treatable by a stem cell transplant.
Select...
I am between 18-50 years old and need a transplant for my blood disease but refuse high-dose treatment.
Select...
My leukemia has less than 5% marrow blasts before transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year post-hct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year post-hct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chronic graft versus host disease (GVHD)-free, relapse-free survival (CRFS)
Secondary outcome measures
Bone Transplantation
Late graft versus host disease (GVHD) not meeting National Institute of Health (NIH) consensus criteria for chronic GVHD
Moderate and severe chronic graft versus host disease
+4 moreSide effects data
From 2019 Phase 2 trial • 77 Patients • NCT012515755%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (cyclosporine, sirolimus, cyclophosphamide)Experimental Treatment4 Interventions
Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4.
Group II: Arm I (mycophenolate mofetil, cyclosporine, sirolimus)Experimental Treatment4 Interventions
Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Cyclosporine
1997
Completed Phase 3
~1830
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Sirolimus
2013
Completed Phase 4
~2750
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,085 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,108 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is approved by the trial's lead researcher.My lymphoma is fast-growing and not low grade.My blood has at least 5% leukemia cells.I have Waldenstrom's macroglobulinemia and two treatments have not worked for me.My donor and I mismatch for two HLA class I alleles but match for HLA-DRB1 and HLA-DQ.I have high blood pressure that isn't well-controlled despite taking several medications.I have an infection that hasn't improved with treatment.I haven't taken strong chemotherapy drugs, except for some exceptions, in the last 3 weeks.The donor will only donate bone marrow.I have CMML and haven't had induction chemotherapy.I have MDS-EB or AML and haven't had strong chemotherapy or a specific treatment regimen.My blood test shows cancer cells for AML, ALL, or CML.I am not willing to use birth control during and for a year after treatment.My donor is not related and partially matches my HLA type.My donor is a partial match for my transplant.My donor is a match for HLA class I and may have up to two mismatches in DRB1 or DQB1.My donor has a partial HLA match with me, fitting the specific criteria for a transplant.My AML is in remission with less than 5% marrow blasts.I have CML and either TKIs didn't work for me or I couldn't tolerate them.My genetic match for the transplant is nearly perfect, with only one minor difference.My donor must fully match and have no preexisting conditions that could affect the transplant.My donor and I do not have a two-allele mismatch.My heart's pumping ability is significantly reduced.My liver functions normally without serious diseases like cirrhosis or severe hepatitis.I am a donor without HIV or conditions that increase risk during stem cell donation.I have a fungal infection that didn't improve after 1 month of specific treatment.My lung function is severely impaired or I need extra oxygen.The study's lead investigator has approved my participation despite having lung nodules.My donor's HLA type does not match mine exactly at a specific genetic spot.My donor is not a full HLA match but matches at key HLA points.I do not have active cancer (except skin cancer) or a high risk of cancer returning within 5 years.I am 18-50 years old with a blood disease, at high risk due to my medical history.I have CLL and my previous treatments have not been successful or I cannot tolerate them.My bone marrow has less than 5% cancer cells at the time of my transplant.I am between 18 and 50 years old with chronic lymphocytic leukemia.I have mantle cell lymphoma and am in my first complete remission.My donor is unrelated but matches my HLA from grades 1.0 to 2.1.My leukemia has less than 5% marrow blasts before transplant.My stem cell donor will use G-CSF for stem cell collection.My brain or spinal cord cancer hasn't responded to chemotherapy in the spine.My BPDCN is currently in complete remission.I have multiple myeloma and have been treated with chemotherapy before.My donor and I are a close match for bone marrow transplant.My Hodgkin lymphoma did not respond to the first treatment I received.I have an aggressive type of non-Hodgkin lymphoma and am not a candidate for certain stem cell transplants.I am over 50 and have a blood cancer treatable by a stem cell transplant.I am between 18-50 years old and need a transplant for my blood disease but refuse high-dose treatment.I am not pregnant or breastfeeding.My leukemia has less than 5% marrow blasts before transplant.My organs are not working properly.My low-grade non-Hodgkin lymphoma remission lasted less than 6 months between treatments.My health severely limits my ability to care for myself.You have HIV.I am currently receiving hemodialysis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (cyclosporine, sirolimus, cyclophosphamide)
- Group 2: Arm I (mycophenolate mofetil, cyclosporine, sirolimus)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we looking for more participants in this experiment?
"Yes, that is correct. This information can be found on the website clinicaltrials.gov. The trial was posted on September 11th, 2017 and updated for the last time on May 18th, 2022. They are searching for a total of 160 patients from 1 site."
Answered by AI
How many people are being observed in this research project?
"The correct answer is that this clinical trial, which was posted on September 11th, 2017 and last edited on May 18th, 2022, is still recruiting patients. They are looking for 160 participants from 1 site."
Answered by AI
Allogeneic Hematopoietic Stem Cell Transplantation: how risky is it, really?
"There is some clinical data supporting the safety of Allogeneic Hematopoietic Stem Cell Transplantation, but none yet for efficacy. Therefore, it received a score of 2."
Answered by AI
Could you please share if this is the first time Allogeneic Hematopoietic Stem Cell Transplantation has been studied?
"At the moment, there are 1051 active studies related to Allogeneic Hematopoietic Stem Cell Transplantation with 189 of those in Phase 3. Many trials for Allogeneic Hematopoietic Stem Cell Transplantation originate from Philadelphia, Pennsylvania; however, 29845 locations operate clinical trials concerning Allogeneic Hematopoietic Stem Cell Transplantation."
Answered by AI
What is the primary purpose of Allogeneic Hematopoietic Stem Cell Transplantation?
"Allogeneic Hematopoietic stem cell transplantation is a course of treatment that can be used to manage leukemia. Additionally, this intervention has been found to ocular rosacea, different types of lung cancer, and organ transplant patients."
Answered by AI
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