A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)

ConditionGraft-versus-host Disease (GVHD)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorIncyte Corporation

About this trial

The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18.0 years or older at the time of enrollment.

Acute leukemia or chronic myelogenous leukemia with no circulating blasts and with less than 5% blasts in the bone marrow. Therapy related myeloid neoplasms are allowed.

Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with < 5% versus 5-10% blasts in this disease). Therapy related myeloid neoplasms are allowed.

Lymphoma [follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma and anaplastic large cell lymphoma].

Disqualifiers

Prior allogeneic transplant.

Active CNS involvement by malignant cells.

Participants with secondary AML arising from myeloproliferative neoplasms or secondary AML arising from overlap syndromes, including CMML and MDS/MPN syndromes; participants with secondary AML arising from myelodysplastic neoplasm are eligible.

Participants with primary, post-Essential Thrombocythemia (post-ET) and post-Polycythemia Vera (post-PV) myelofibrosis.

Trial design

Design model

Parallel

Treatments tested in this trial

Tacrolimus (Tac)
Drug
Tablet or intravenously (IV)
Methotrexate (MTX)
Drug
Intravenously (IV)
Ruxolitinib (Rux)
Drug
Tablet
Cyclophosphamide
Drug
Intravenously (IV)
Mycophenolate mofetil (MMF)
Drug
Tablet or intravenously (IV)

Treatment groups

572 Participants

are divided into 4 treatment groups

Group A: Dose Finding Run-In Group 1: Tac/MTX/Ruxolitnib Dose 1Experimental treatment 3 interventions

Group B: Dose Finding Run-In Group 2: Tac/MTX/Ruxolitnib Dose 2Experimental treatment 3 interventions

Group C: Main Study Group A: Tac/MTX/RuxolitnibExperimental treatment 3 interventions

Group D: Main Study Group B: PTCy/Tac/MMFActive comparator 3 interventions

Trial outcomes

Primary outcomes

GVHD-free survival (GFS)

GFS will be defined as the elapsed time between the date of transplant to Grade III-IV acute graft-versus host disease (GVHD), chronic GVHD requiring systemic immune suppression, or death by any cause.

Time frame