A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT07359859
This study evaluates two GVHD prophylaxis strategies post-allo-HCT in patients with hematologic malignancies in remission. Eligible participants are adults with a Karnofsky score ≥70% and specific contraceptive measures. Interventions include varying doses of Cyclophosphamide, Mycophenolate Mofetil, Ruxolitinib, and Tacrolimus, with specific administration schedules.
Patient Parameters
| Parameter | Options |
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Program Overview
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
Eligibility Criteria
Inclusion Criteria
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Patients ≥18- years-old at time of consent
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Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
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Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
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Karnofsky score ≥ 70%
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Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
°Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: *Intrauterine device (IUD) plus one barrier method *Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method *2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or * A vasectomized partner.
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For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
Exclusion Criteria
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Uncontrolled psychiatric illness
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | 11553 | Rockville Centre | New York |
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