Ruxolitinib for Preventing Graft-Versus-Host Disease in Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two methods to prevent graft-versus-host disease (GVHD), a potential complication after a stem cell transplant in individuals with blood cancers. One method uses the drug ruxolitinib, a JAK inhibitor, alongside other medications. Researchers aim to determine which approach better prevents GVHD up to a year post-transplant. This trial may suit those in remission from blood cancers such as leukemia or lymphoma who have received a stem cell transplant. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ruxolitinib is generally well-tolerated. Studies have demonstrated improved outcomes for patients with graft-versus-host disease (GVHD). One study found that 10.4% of patients experienced moderate to severe acute GVHD, indicating manageable side effects. Another study showed that 78.3% of patients with severe chronic GVHD responded well to the treatment.
Some studies noted slightly higher rates of chronic GVHD with ruxolitinib compared to other treatments, but the difference was not significant. This suggests that ruxolitinib's safety is comparable to other treatments. Overall, ruxolitinib appears to be a safe option for those dealing with GVHD.12345Why do researchers think this study treatment might be promising?
Ruxolitinib is unique because it targets the JAK1 and JAK2 enzymes, which play a crucial role in inflammatory responses. This mechanism of action is different from the standard graft-versus-host disease (GVHD) prevention treatments, which typically rely on immunosuppressants like PTCY, tacrolimus, and MMF. Researchers are excited about ruxolitinib because it offers a more targeted approach, potentially reducing inflammation and improving outcomes with fewer side effects. This novel approach may lead to better protection against GVHD in patients undergoing treatment for blood cancers.
What evidence suggests that this trial's treatments could be effective for preventing GVHD?
Research has shown that ruxolitinib might help prevent chronic graft-versus-host disease (GVHD) after stem cell transplants. In this trial, one arm will receive an intermediate dose of PTCY, tacrolimus, MMF, and ruxolitinib. One study found that using ruxolitinib for a longer period reduced the occurrence of moderate-to-severe chronic GVHD to 16%. Another study showed that the drug lowered the rate of acute GVHD (a quicker form of the disease) to 7.8%, compared to 36.9% in those not taking it. These studies suggest that ruxolitinib could effectively reduce the risk of both acute and chronic GVHD in transplant patients.16789
Who Is on the Research Team?
Doris Ponce, MD, MS
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with blood cancers in remission, needing a stem cell transplant, can join. They must have a matched donor and be healthy enough (Karnofsky score ≥70%). Women under 50 must test negative for pregnancy and use two contraceptives; men should too and not donate sperm.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either an intermediate dose of PTCY, tacrolimus, MMF, and ruxolitinib or a full dose of PTCY, tacrolimus, and MMF
Follow-up
Participants are monitored for chronic GVHD-free survival and incidence of grade 2-4 infections
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib
Trial Overview
The study compares two ways to prevent chronic GVHD after an allo-HCT: one using Ruxolitinib combined with other drugs, versus another standard approach. It aims to see which is better up to one year post-transplant.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
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
Citations
Ruxolitinib treatment outcomes in acute graft-versus-host ...
The three-year OS was 64.1% (95% CI: 48.2–76.3). Ruxolitinib appears effective and safe in real-world practice. The presented data is in line with the results ...
Final Analysis From the Randomized Phase III REACH2 Trial
Numerically higher chronic GVHD rates were noted with ruxolitinib than with BAT from 12 months; however, 95% confidence intervals overlapped.
Efficacy and safety of ruxolitinib for graft-versus-host ...
Our meta-analysis indicates improved outcomes with ruxolitinib, showing a 10.4% incidence of grades II–IV acute GVHD and a 2.9% rate for grades ...
4.
cancernetwork.com
cancernetwork.com/view/low-rates-of-chronic-graft-versus-host-disease-with-ruxolitinib-maintenance-following-allogeneic-hctLow Rates of Chronic Graft-Versus-Host Disease With ...
Results indicated that prolonged ruxolitinib maintenance significantly reduced rates of moderate-to-severe cGVHD, with an incidence of only 16% ...
5.
ashpublications.org
ashpublications.org/blood/article/145/20/2236/537129/Prevention-is-better-than-curePrevention is better than cure | Blood - ASH Publications
The incidence of grade 2 to 4 aGVHD was significantly lower in the ruxolitinib group (7.8% vs 36.9%). Moderate to severe cGVHD was also ...
Efficacy and safety of ruxolitinib for graft-versus-host disease ...
Our meta-analysis indicates improved outcomes with ruxolitinib, showing a 10.4% incidence of grades II–IV acute GVHD and a 2.9% rate for grades ...
Long-term follow-up results of ruxolitinib as salvage ...
Most patients presented with severe chronic graft-versus-host disease (15/23; 65.2%). The overall response rate was 78.3% (18/23) after a median treatment ...
8.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/654/503361/Ruxolitinib-in-Patients-With-Chronic-Graft-Versus3-Year Final Analysis of Efficacy and Safety From the Phase III ...
Ruxolitinib in patients with chronic graft-versus-host disease: 3-year final analysis of efficacy and safety from the Phase III REACH3 study.
Efficacy and safety of ruxolitinib in steroid-refractory graft- ...
This study suggests that ruxolitinib is an effective and safe treatment for SR-GVHD, and both children and adults with SR-GVHD could benefit from ruxolitinib ...
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