Graft Versus Host Disease (GvHD) Clinical Trials

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Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥18- years-old at time of consent

• 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

• Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical

• Karnofsky score ≥ 70%

• 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.

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITING
Rockville Centre
Contact Information
Primary
Doris Ponce, MD, MS
BMTTrials@mskcc.org
646-608-3739
Backup
Brian Shaffer, MD
646-608-3737
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2029-01
Participants
Target number of participants: 40
Treatments
Experimental: An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib
will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib
Active_comparator: A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Incyte Corporation

This content was sourced from clinicaltrials.gov