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Clinical Trial 19204

Cancer Type:
Interventions:Cellcept (Mycophenolate Mofetil); Gleevac (Imatinib Mesylate); Imatinib Mesylate; Infliximab (Remicade); Jakafi (Ruxolitinib); Mycophenolate Mofetil; Pentostatin; Rapamune (Sirolimus); Rapamycin (Sirolimus); Rituxan (rituximab); Ruxolitinib; STI571 (Imatinib Mesylate); Sirolimus; everolimus (RAD001); methotrexate; rituximab

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Joseph Pidala

Overview

Study Title

A Phase III Randomized Open-Label Multi-Center Study of Ruxolitinib vs. Best Available Therapy in Patients with Corticosteroid-Refractory Chronic Graft vs Host Disease after Allogeneic Stem Cell Transplantation (REACH 3)

Summary

The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).

Objective

Primary Objective: To compare the efficacy of ruxolitinib versus Investigator's choice Best Available Therapy (BAT) in patients with moderate or severe SR-cGvHD assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 visit. Key Secondary Objectives: To compare the rate of failure free survival (FFS) and the change in the modified Lee cGvHD Symptom Scale score between treatment groups. FFS will be used as the first key secondary endpoint for all regions except in the US and the change in modified Lee cGvHD Symptom Scale score will be compared thereafter. In the US, the order will be reversed.

Inclusion Criteria

  • Have undergone allogeneic stem cell transplantation (alloSCT) from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.
  • Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm^3 and platelet count > 25,000/ mm^3.
  • Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization: Moderate cGvHD: At least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1; Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3.
  • Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks, OR; Increase to prednisolone dose to > 0.25 mg/kg/day after 2 unsuccessful attempts to taper the dose.
  • Participant must accept to be treated with only one of the following BAT options on Cycle 1 Day 1 (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib.

  • Exclusion Criteria

  • Participants who have received 2 or more systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
  • Patients that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment. * Patients receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.
  • Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1
  • Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
  • Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
  • Steroid refractory cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for preemptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible
  • Any corticosteroid therapy for indications other than cGvHD at doses > 1 mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1