Protocol Summary

Protocol No.: OCR16060

Sponsor Protocol No.: 18424-365

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 allogenic stem cell transplantation (REACH 3)

Principal Investigator(s)
Farhadfar, Nosha

Objective
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).

Phase: Phase III

Age Group: Both

Scope: National

Treatment
Ruxolitinib
Ruxolitinib for the treatment period and extension period.

Best Available Therapy
Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 12 years old and older
2. Have undergone allogenic 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
3. Evident myeloid and platelet engraftment: Absolute neutrophil count (ANC) > 1000/mm^3 and platelet count > 25,000/ mm^3
4. 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
5. Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of - A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week, OR
- Disease persistence without improvement despite continued treatment with prednisone at > 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
6. 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

EXCLUSION CRITERIA:
1. Participants who have received systemic treatment for cGvHD in addition to corticosteroids ± CNI for cGvHD
2. Participants with overlap syndrome, defined as presence of simultaneous features of both cGvHD and acute GvHD (aGvHD), or participants that transition from aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment
3. 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
4. Failed prior alloSCT within the past 6 months from Cycle 1 Day 1
5. Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed
6. 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
7. 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

Applicable Disease Sites
Stem Cell Transplant
Supportive Care Trials

Participating Institutions
UF Gainesville : Zachary Hudson

Contact
Zachary Hudson
Phone: +1 352-294-8907

Email: zachary.hudson@medicine.ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT03112603