Cyclophosphamide-Based Prophylaxis for Leukemia
(ACCELERATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to identify the best drug combination to prevent graft-versus-host disease (GVHD), a common complication after a stem cell transplant from an unrelated donor with a different blood type. Participants will receive either a new drug combination, including cyclophosphamide (a chemotherapy drug), or the standard treatment. They will attend regular check-ups and tests. This study targets individuals with specific types of leukemia or myelodysplastic syndromes (MDS) who have a partially matched donor and no active disease in their blood or organs. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in GVHD prevention.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of cyclophosphamide, mycophenolate mofetil, and tacrolimus has been studied for safety. Some studies suggest this combination might help people live longer without experiencing graft-versus-host disease (GVHD), a positive outcome. However, risks exist. For instance, using these drugs together can slow the growth of new blood cells after a transplant, potentially increasing the risk of infections and other side effects.
Cyclophosphamide is already used in other treatments, so doctors have extensive experience with it, providing some reassurance about its safety. However, individual reactions can vary. Discuss any concerns with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Most treatments for leukemia involve chemotherapy drugs, but researchers are excited about cyclophosphamide because it offers a promising approach for prophylaxis, or prevention, of the disease. Unlike many standard treatments that target leukemia after it has developed, cyclophosphamide may help in preventing the onset of leukemia in at-risk individuals. This drug works by suppressing the immune system in a specific way, potentially stopping leukemia cells from multiplying before they become problematic. By focusing on prevention, cyclophosphamide could revolutionize how we approach leukemia, shifting from treatment to prevention and potentially improving long-term outcomes for patients.
What evidence suggests that this trial's treatments could be effective for preventing graft-versus-host disease?
Research has shown that a combination of three drugs—cyclophosphamide, tacrolimus, and mycophenolate mofetil—may help prevent graft-versus-host disease (GVHD) after stem cell transplants. In this trial, participants in the ACCEL-001 and ACCEL-002 arms will receive different interventions involving these drugs. Studies have found that using cyclophosphamide with these drugs can lead to fewer relapses and better survival rates. Specifically, one study reported that only 4% of patients died from causes other than relapse after 36 months. Another study found that overall survival rates improved when cyclophosphamide was used with tacrolimus and mycophenolate mofetil. These findings suggest that this drug combination might effectively prevent GVHD in transplant patients.13678
Are You a Good Fit for This Trial?
This trial is for people with certain blood cancers who need a stem cell transplant from an unrelated donor with different blood cells. They must be willing to follow the study plan, have less than 10% cancer cells in their bone marrow, and meet specific health criteria like good heart function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants undergo myeloablative or reduced-intensity conditioning prior to transplant
Transplantation
Participants receive mismatched unrelated donor peripheral blood stem cell transplantation
Treatment
Participants receive post-transplant cyclophosphamide-based GVHD prophylaxis and are assigned to either the standard or new drug combination
Follow-up
Participants are monitored for safety and effectiveness, including assessments of graft-versus-host disease-free survival, infection-free survival, and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Mycophenolate mofetil
- Tacrolimus
Trial Overview
Researchers are testing new drug combinations against standard ones to prevent graft-versus-host disease after a stem cell transplant. Participants will receive drugs post-transplant, attend regular check-ups, complete well-being surveys, and provide blood and stool samples.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Shared comparator control group
Intervention 2
Intervention 1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Center for International Blood and Marrow Transplant Research
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
National Marrow Donor Program
Collaborator
Citations
Post-Transplant Cyclophosphamide and Tacrolimus ...
After a 36-month median follow-up, NRM was 4%; median event-free survival (EFS) and overall survival (OS) had yet to occur. One- and two-year ...
a study from the acute leukemia working party (EBMT)
Our study demonstrates similarly favorable OS and GRFS with both TAC and CSA combined with PT-Cy/MMF. TAC was associated with less severe acute ...
Post-Transplantation Cyclophosphamide-Based Graft ...
A phase 2 study indicated the potential superiority of a post-transplantation regimen of cyclophosphamide, tacrolimus, and mycophenolate mofetil.
Mycophenolate Mofetil: A Friend or a Foe with Post- ...
Post-transplantation cyclophosphamide (PTCy)/tacrolimus (Tac)/mycophenolate mofetil (MMF) was associated with a lower risk of relapse, better ...
Post-Transplant Cyclophosphamide and Tacrolimus ...
This study explored the performance of PTCy infusion, measured by transplant morbidity and outcome, when added to tacrolimus/mofetil mycophenolate (T/MMF) as ...
Graft-versus-Host Disease Prophylaxis with ...
The combination of post-transplantation cyclophosphamide and a calcineurin inhibitor led to longer GVHD-free, relapse-free survival than standard prophylaxis.
Study Details | NCT00255710 | Cyclophosphamide and/or ...
This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients.
Paper: Post-Transplant Cyclophosphamide, Tacrolimus or ...
Recently, the BMT CTN 1703 phase III study compared post-transplant cyclophosphamide with tacrolimus with mycophenolate mofetil (PTCy/TAC/MMF) ...
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