A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07359859
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    An intermediate dose (medium dose) of Post-transplant Cyclophosphamide
  • Cyclophosphamide — DRUG
    A full dose of Post-transplant Cyclophosphamide
  • Mycophenolate Mofetil — DRUG
    Day +5 to +35
  • Ruxolitinib — DRUG
    twice a day
  • Tacrolimus — DRUG
    Day +5, taper per SoC
  • Tacrolimus — DRUG
    Day +5, taper initiation within 2 weeks of starting Ruxolitinib

Study Details

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).

Key Dates

Start date
Jan 20, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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)

Primary Outcome Measure

assess cGVHD-free survival [ Time Frame: 1 year post-HCT ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Doris Ponce, MD
646-608-3739
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Doris Ponce, MD
646-608-3739

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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