Itacitinib for Graft-versus-Host Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding itacitinib, a JAK inhibitor, to the usual treatment can help prevent graft-versus-host disease (GVHD) in individuals who have received a donor stem cell transplant. GVHD occurs when donor cells attack the recipient's body cells. The trial targets patients with blood disorders who are about to undergo a specific type of stem cell transplant from a matched donor. It suits those who have undergone or will undergo this transplant and seek to prevent GVHD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that itacitinib is likely to be safe for humans?
Research has shown that itacitinib is safe for humans. In an earlier study, itacitinib did not harm the process where transplanted cells grow and produce healthy blood cells. Another study found that patients did not experience severe cases of cytokine release syndrome (CRS), an immune system overreaction. Most patients had no CRS or only mild symptoms. These findings indicate that itacitinib is generally well-tolerated, with few serious side effects, suggesting its safety for patients treated for graft-versus-host disease.12345
Why do researchers think this study treatment might be promising for GVHD?
Most treatments for graft-versus-host disease (GVHD), like corticosteroids, work by broadly suppressing the immune system. But itacitinib stands out because it specifically targets the JAK1 pathway, which plays a key role in the inflammatory process of GVHD. This targeted approach might reduce the unwanted side effects often seen with generalized immune suppression. Researchers are excited because itacitinib could offer a more precise treatment option, potentially improving patient outcomes while minimizing complications.
What evidence suggests that itacitinib might be an effective treatment for graft-versus-host disease?
Research has shown that itacitinib, which participants in this trial will receive as part of supportive care, can help prevent graft-versus-host disease (GVHD). This condition occurs when the donor's cells attack the patient's body after a stem cell transplant. Earlier studies found that itacitinib effectively stopped severe GVHD without increasing the risk of transplant failure. More patients responded positively to itacitinib within just 7 days compared to other treatments, and these positive results continued at 28 days. Long-term results for itacitinib were similar to traditional treatments like corticosteroids, and itacitinib was also found to be safe. These studies suggest that itacitinib could be a promising option for reducing the risk of GVHD after transplants.14678
Who Is on the Research Team?
Uday R. Popat
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with blood disorders who are undergoing a stem cell transplant from a donor. They must have good organ function, agree to use contraception, and not be pregnant. People with serious heart conditions, active hepatitis B or C, or unresolved treatment side effects can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Patients receive busulfan, thiotepa, and fludarabine as part of the conditioning regimen before stem cell transplant
Stem Cell Transplant
Patients undergo stem cell transplant
GVHD Prophylaxis
Patients receive cyclophosphamide, itacitinib, and tacrolimus to prevent graft-versus-host disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Itacitinib
Trial Overview
The study is testing if adding Itacitinib to standard treatments (Cyclophosphamide, Tacrolimus) after a stem cell transplant can prevent graft-versus-host disease—a condition where donor cells attack the patient's body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
CONDITIONING: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3. STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib PO QD on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO BID.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson 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
Published Research Related to This Trial
Citations
1.
ashpublications.org
ashpublications.org/blood/article/145/13/1382/526136/Itacitinib-for-prevention-of-graft-versus-hostItacitinib for prevention of graft-versus-host disease and ...
Itacitinib was extremely effective at preventing grade 2 to 4 CRS and grade 3/4 aGVHD, with no clear increase in relapse rate. Itacitinib was ...
Effective treatment of low-risk acute GVHD with itacitinib ...
More patients responded to itacitinib within 7 days (81% vs 66%, P = .02), and response rates at day 28 were very high for both groups (89% vs ...
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT04127721?term=Graft-versus-Host%20Disease%20and%20stem%20cells&viewType=Table&rank=6Itacitinib for the Prevention of Graft Versus Host Disease in ...
This phase II trial studies how well itacitinib works in preventing graft versus host disease in patients with blood disorders undergoing donor stem cell ...
Itacitinib appears effective for acute graft-versus-host disease
Long-term outcomes appeared comparable between itacitinib and systemic corticosteroids, with similar risk for chronic GVHD, findings presented ...
Itacitinib (INCB039110) and Extracorporeal Photopheresis ...
Participants were assessed for chronic graft versus host disease (GVHD) severity per the NIH Consensus Development Project Criteria at baseline, after 24 weeks ...
6.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-announces-results-phase-3-study-itacitinib-patientsIncyte Announces Results of Phase 3 Study of Itacitinib in ...
GRAVITAS-301 results show that treatment with itacitinib in combination with corticosteroids did not statistically improve overall response rate or non-relapse ...
Efficacy and safety of itacitinib versus placebo in ...
We aimed to evaluate the Janus kinase 1 inhibitor itacitinib versus placebo, both in combination with corticosteroids, for initial treatment of acute GVHD.
Itacitinib for prevention of graft-versus-host disease and ...
Itacitinib resulted in low CRS grades, all patients had grade 0 (22%) or grade 1 (78%) CRS and there were no cases of grade 2 to 5 CRS. There ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.