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

ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinibExperimental treatment 4 interventions
Group B: A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

assess cGVHD-free survival

Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.

Time frame
1 year post-HCT

Secondary outcomes

1

incidence of grade 2-4 infections.

Grade 2-4 infections by CTCAE v5 either clinically or microbiologically will be assessed throughout the study until day +365. Causality and relationship with ruxolitinib will be determined.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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