A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

Conditions

• Graft-versus-host Disease (GVHD)

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  Ruxolitinib twice daily at the protocol-defined starting dose.
• Extracorporeal photopheresis (ECP) — DRUG
  Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study).
• Low-dose methotrexate (MTX) — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Mycophenolate mofetil (MMF) — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus) — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Infliximab — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Rituximab — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Pentostatin — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Imatinib — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
• Ibrutinib — DRUG
  Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.

Study Details

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).

Key Dates

Start date

Jun 29, 2017

Status verified

Aug 2025

Primary completion

May 8, 2020

Completion

Dec 15, 2022

Study Design

Enrollment

330 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib
  Ruxolitinib for the treatment period and extension period.
• Active Comparator: Best Available Therapy
  Best available therapy for the treatment period and extension period, with optional crossover to ruxolitinib after Cycle 6.

Primary Outcome Measure

Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit [ Time Frame: Cycle 7 Day 1 (each cycle was comprised of 4 weeks) ]

Locations (38)

Find similar trials in Tucson, AZ

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