New drug cocktail aims to tame deadly transplant complication
NCT ID NCT07570745
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a new oral drug (ivarmacitinib) to standard medicines can prevent a serious complication called graft-versus-host disease (GVHD) after a stem cell transplant from a female donor who has given birth. About 82 adults with blood cancers will receive the drug combo and be monitored for 6 months. The goal is to reduce severe GVHD while keeping the transplant working.
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 82 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
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: 1. Age 18-70 years, any gender. Recipients must be diagnosed with hematologic malignancies, such as acute leukemia, myelodysplastic syndrome, or malignant lymphoma, and are planned to undergo haploidentical peripheral blood stem cell transplantation (Haplo-PBSCT). 2. The donor must be a haploidentical relative within three degrees of kinship and a parous female (having given birth; number of pregnancies not limited), aged 18-55 years, in good health, and cleared by donor screening. 3. Karnofsky performance status ≥70. The recipient is expected to tolerate transplant-related toxicity. Major organ functions must meet transplantation requirements: cardiac and pulmonary function essentially normal; liver function: ALT/AST \<2× upper limit of normal, total bilirubin \<1.5× upper limit of normal; renal function: creatinine clearance \>50 mL/min. 4. No active infection prior to transplantation (or infection effectively controlled). Chronic infections such as HBV, HCV, or syphilis must be stable under treatment; HBV DNA negative or receiving antiviral therapy is acceptable. 5. No significant psychiatric disorders; able to understand and voluntarily consent to participate in the study. 6. The patient has signed the informed consent form and agrees to comply with follow-up and related examinations. Exclusion Criteria: 1. History of prior hematopoietic stem cell transplantation (including autologous or allogeneic transplant). 2. Presence of donor-specific antibodies (DSA) with a mean fluorescence intensity (MFI) ≥5000. 3. History of severe hypersensitivity or allergy to JAK inhibitors or the investigational drug. 4. Prior treatment with JAK1/2 inhibitors. 5. Uncontrolled comorbidities prior to transplantation, such as uncontrolled hypertension, diabetes complications, or active gastrointestinal ulcer bleeding, which may increase unacceptable risk for trial participation as evaluated by investigators. 6. Receipt of other investigational drugs within 2 weeks prior to transplantation (excluding standard chemotherapy), or simultaneous participation in other interventional clinical studies, or any other condition deemed by the investigator to make the patient unsuitable for study participation, including poor compliance or inability to complete follow-up (e.g., severe psychiatric disorders preventing cooperation).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai General Hospital Affiliated to Shanghai Jiao Tong University
RECRUITINGShanghai, Shanghai Municipality, 210000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a lung protein tame severe graft-versus-host disease?
- 10,000 DNA samples could reveal hidden genetic triggers for leukemia and lymphoma