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Cyclophosphamide + Tacrolimus + Mycophenolate for Preventing Graft Versus Host Disease in Blood Cancers
Study Summary
This trial tests how well high doses of cyclophosphamide, tacrolimus, and mycophenolate mofetil prevent graft versus host disease in patients with blood cancer undergoing stem cell transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had a transplant using cells from a donor.Your bilirubin level must be within a certain range, but if you have Gilbert's disease, you may be allowed to have higher bilirubin levels.You have tested positive for HIV.You have a current, active hepatitis B or C infection confirmed by a specific blood test.You have had another type of cancer that has not been under control for at least 3 years.The participant has a donor who is a good match for the transplant.You have myelodysplastic syndrome (MDS) with a high risk of getting worse, or myeloproliferative neoplasm with high-risk features or a disease that does not respond to treatment.You have a donor who is not related to you but is a good match for a transplant.You do not have a lot of leukemia cells in your blood or bone marrow.You have a high risk of, or your multiple myeloma has not responded well to previous treatments.You do not have a close family member who is a suitable match for a stem cell or bone marrow transplant.Your heart's pumping ability at rest is at least 50%.The donor must have specific genetic markers that match the recipient's genes.You had a heart attack in the past 6 months, have severe heart failure, uncontrolled chest pain, or serious heart rhythm problems.You have certain types of blood cancers that respond well to chemotherapy.Your alkaline phosphatase levels are not more than 2.5 times the upper limit of normal.Your liver enzymes (ALT/AST) are not more than 2.5 times the normal level.Cancer has spread to the brain or spinal cord.You have a specific type of lymphoma that has changed from a previous type of lymphoma or leukemia.You don't have anyone to help take care of you, or you don't follow your doctor's instructions for taking medications.You are able to perform daily activities and take care of yourself without much difficulty.Your kidneys are working well if you are between 5 and 12 years old.You have good lung function, as measured by specific breathing tests.You do not have specific antibodies against the donor's HLA-type.
- Group 1: Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)
- Group 2: Regimen C (fludarabine, TBI, PBSC HCT, GVHD prophylaxis)
- Group 3: Regimen A (fludarabine, melphalan, PBSC HCT, GVHD prophylaxis)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants have been accepted into this research project?
"Unfortunately, no more enrolments for this particular study are being accepted. Originally posted on May 30th 2017 and last edited on November 18th 2022, the trial is now closed. If you're seeking alternate opportunities to contribute data as a research participant, there are currently 6033 studies with hematologic neoplasms that have open recruitment periods, in addition to 1072 trials with Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)."
What health issues is the Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) combination typically employed to address?
"Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) can be administered to patients with hematopoietic stem cells deficiencies, leukemia or lung cancer."
Is the age threshold for participant eligibility in this investigation over 25?
"According to the stated parameters, individuals must be of between 5 and 75 years old in order to qualify for enrolment."
Are researchers seeking additional participants for this analysis?
"Currently, no new patients are being recruited for this trial. It was posted on May 30th 2017 and last modified on November 18th 2022. Those interested in other clinical trials focusing on hematologic neoplasms may find 6033 active studies while 1072 Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) related medical experiments require volunteers."
Does my medical profile meet the qualifications to partake in this experiment?
"38 individuals with hematologic neoplasms spanning from 5 to 75 years of age are admitted for this research. In order to be eligible, a set criteria must be followed: the lack of an HLA-matched related donor; availability of matched unrelated donors; and ejection fraction at rest that is greater than or equal to 50%. Moreover, patients afflicted with high risk or refractory/relapsed multiple myeloma in addition to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular marginal zone diffuse large B-cell Hodgkin's Lymphoma, and mantle cell lymphomas can all qualify provided they"
What evidence is available to assess the security of Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis) for patients?
"Our risk assessment team at Power scored Regimen B (fludarabine, busulfan, PBSC HCT and GVHD prophylaxis) with a 2 due to the evidence collected from Phase 2 trials demonstrating safety but no efficacy."
What other scientific assessments have assessed the efficacy of Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis)?
"Presently, 1072 clinical trials are investigating Regimen B (fludarabine, busulfan, PBSC HCT, GVHD prophylaxis). Of these active studies in progress, 192 of them have reached Phase 3. Philadelphia holds the majority of trials for this treatment with regards to location; however 30493 medical sites across the nation are conducting research on this prescription regimen."
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