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Comparing Drug Combinations to Prevent GVHD After Transplant for AML

This study is comparing two different drug combinations to prevent graft-versus-host disease (GVHD) after a stem cell transplant for acute myeloid leukemia (AML). GVHD is a complication where the new immune cells from the donor attack the patient's body. One group will receive cyclophosphamide, sirolimus, and Mycophenolate Mofetil. The other group will receive cyclophosphamide, sirolimus, and ruxolitinib. We want to see which combination is better at preventing GVHD and improving overall health. You may be eligible if you are 65-75 years old with AML, myelodysplastic syndrome, or chronic myelomonocytic leukemia, and have a suitable donor. The main goal is to see how safe these treatments are and how well they prevent GVHD.

Study design
This is a randomized study, meaning participants will be assigned by chance to one of the two treatment groups. We plan to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and any side effects will be monitored through study completion, which is expected to be an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06973668

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

Recruiting
PHASE2Ages 65–75InterventionalTreatment
M.D. Anderson Cancer Center
~80 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Mycophenolate MofetilRuxolitinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

AML

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Uday Popat, MBA,MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Uday Popat, MBA,MD
[email protected]
(713) 563-0812
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

DLCO corrected for Hgb, if applicable) ≥ 50% of predicted
Ejection Fraction ≥ 50%
The effects on the developing human fetus are unknown. For this reason and as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
History of hysterectomy or bilateral salpingo-oophorectomy.
Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0