New drug aims to stop transplant attack on the body
NCT ID NCT04859946
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether the drug itacitinib, given with standard care, can prevent graft-versus-host disease (GVHD) in people who receive a donor stem cell transplant for blood cancers. GVHD happens when the donor cells attack the patient's body. The study includes 31 adults aged 18 to 70 who are getting a matched donor transplant. Researchers will track how many develop moderate to severe GVHD within 100 days and how long they stay free of both GVHD and cancer relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Itacitinib (a drug that may calm the immune system)
- What this could lead to
- If it works, this could point toward a way to prevent graft-versus-host disease, a serious complication of donor stem cell transplants.
- What could go wrong
- This is a small, early-phase trial with only 31 participants, so results may not apply to everyone. Itacitinib may not reduce GVHD and could have side effects like infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 18 years to less than or equal to 70 years * English and non-English speaking patients are eligible * Karnofsky performance status of at least 70 * Patients with hematological disorders undergoing allogeneic stem cell transplant (ASCT) with conditioning regimen of fractionated busulfan, thiotepa and fludarabine * Donor will be matched at HLA A, B, C and DR at allele level. Donor will be either HLA-identical sibling or at least 7/8 matched unrelated donor, or a haploidentical related donor available. * Life expectancy of at least 12 weeks (3 months) * Direct bilirubin not greater than 1 mg/dL * Alanine transaminase (ALT) less than or equal 3 x upper limit of normal range * Creatinine clearance \>/= 60 ml/ min * Diffusing capacity for carbon monoxide (DLCO) 50% of predicted corrected for hemoglobin * Left ventricular ejection fraction (LVEF) of at least 50% * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test * Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug. Recommended methods of birth control are: * Hormonal contraception (birth control pills, patches, or rings) * Intrauterine device (IUD) * Birth control injections * Double barrier methods (diaphragm with spermicidal gel or condoms with birth control foam) * Sterilization of patient or partner ("tubes tied" or vasectomy) * Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI Exclusion Criteria: * Patients with acute leukemia in the first complete remission and chronic myeloid leukemia in the first chronic phase during the initial enrollment of 6 patients * Patients with toxicities (Grade \> 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery) * Haploidentical recipients should not have donor-specific antibodies (DSA) * Active or clinically significant cardiac disease including: * Congestive heart failure - New York Heart Association (NYHA) \> class II * Active coronary artery disease * Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin * Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before transplant, or myocardial infarction within 6 months before transplant * Patients with active hepatitis B and C * Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with safety or with obtaining informed consent or compliance with study procedures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug combo aims to tame deadly transplant complication
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- Engineered immune cells aim to tame chronic GVHD
- Can a drug combo stop AML from coming back?