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Recruiting NCT07359859

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

Phase II Interventional Hematologic Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyclophosphamide, Cyclophosphamide, Mycophenolate Mofetil, Ruxolitinib.
Who it may be relevant to
Registry conditions: Hematologic Malignancies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

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

Primary outcome measures

  • assess cGVHD-free survival [Time frame: 1 year post-HCT]
Secondary outcome measures (1)
  • incidence of grade 2-4 infections. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Recipient of CD34+ selected or engineered stem cell graft
  • Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
  • Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre

Identifiers

NCT: NCT07359859 · 25-212

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗