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)

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).

Conditions

• Graft-versus-host Disease (GVHD)

Interventions

DRUG

Ruxolitinib

Ruxolitinib twice daily at the protocol-defined starting dose.

DRUG

Extracorporeal photopheresis (ECP)

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).

DRUG

Low-dose methotrexate (MTX)

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.

DRUG

Mycophenolate mofetil (MMF)

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.

DRUG

mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)

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.

DRUG

Infliximab

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.

DRUG

Rituximab

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.

DRUG

Pentostatin

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.

DRUG

Imatinib

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.

DRUG

Ibrutinib

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.

Sponsors & Collaborators

• Incyte Corporation

  lead INDUSTRY

Principal Investigators

• Rodica Morariu-Zamfir · Incyte Corporation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-29

Primary Completion

2020-05-08

Completion

2022-12-15

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• Bulgaria
• Canada
• Czechia
• Denmark
• France
• Germany
• Greece
• Hungary
• India
• Israel
• Italy
• Japan
• Jordan
• Netherlands
• Norway
• Poland
• Portugal
• Puerto Rico
• Romania
• Russia
• Saudi Arabia
• South Korea
• Spain
• Sweden
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations