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)



Status:Recruiting
Conditions:Orthopedic, Hematology
Therapuetic Areas:Hematology, Orthopedics / Podiatry
Healthy:No
Age Range:12 - Any
Updated:2/8/2019
Start Date:June 23, 2017
End Date:January 2022
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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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 (REACH3)

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).


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 < 12 months prior to Cycle 1 Day 1 (if applicable), and
have a confirmed diagnosis of steroid-refractory cGvHD defined per 2014 NIH consensus
criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as
follows:

- 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

- 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
We found this trial at
32
sites
New Haven, Connecticut 06510
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Boston, Massachusetts 02114
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Boston, MA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Chicago, Illinois 60611
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Chicago, IL
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Cincinnati, Ohio 45242
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Cleveland, Ohio 44106
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Columbus, Ohio 43210
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Columbus, OH
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Dallas, Texas 75390
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Dallas, TX
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Darlinghurst, New South Wales 2010
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Darlinghurst,
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Duarte, California 31010
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Duarte, CA
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Durham, North Carolina 27710
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Durham, NC
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Gainesville, Florida 32610
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Hackensack, New Jersey 07601
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46237
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Indianapolis, IN
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La Jolla, California 92093
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La Jolla, CA
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Lexington, Kentucky 40536
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Lexington, KY
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Los Angeles, California 90033
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Los Angeles, CA
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Maywood, Illinois 60153
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Maywood, IL
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Nashville, Tennessee 37232
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New York, New York 10065
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New York, NY
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Omaha, Nebraska 68198
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15224
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Seattle, Washington 98109
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Tampa, Florida 33612
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Tucson, Arizona 85724
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Westwood, Kansas 66205
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1801 Augustine Cut Off
Wilmington, Delaware 19803
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Winston-Salem, North Carolina 27157
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