Clinical trial NCT03112603: 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)
Official 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 (REACH3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft-versus-host Disease (GVHD)
Keywords: Graft-versus-host disease (GvHD)
Chronic GvHD (cGvHD)
steroid-refractory
ruxolitinib
Janus kinase inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 330
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
Secondary outcomes:
measure: Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
timeFrame: Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
measure: Rate of Failure-free Survival (FFS)
timeFrame: Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
measure: Rate of FFS at Study Completion
timeFrame: From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years)
measure: Best Overall Response (BOR) at Cycle 7 Day 1
timeFrame: up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
measure: BOR During Cross-over Treatment With Ruxolitinib
timeFrame: from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks)
measure: ORR at the End of Cycle 3
timeFrame: Cycle 4 Day 1 (each cycle was comprised of 4 weeks)
measure: Duration of Response Through Study Completion
timeFrame: from first response to LPLV (approximately 5 years)
measure: Overall Survival (OS)
timeFrame: from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years)
measure: Cumulative Incidence of Non-relapse Mortality (NRM)
timeFrame: Months 3, 6, 12, 18, 24, 30, and 36
measure: Percentage of Participants With a ≥ 50% Reduction in Daily Corticosteroid Dose
timeFrame: from Day 15 up to Day 182
measure: Percentage of Participants Successfully Tapered Off of All Corticosteroids
timeFrame: up to Day 179
measure: Cumulative Incidence of Malignancy Relapse/Recurrence (MR)
timeFrame: Months 3, 6, 12, 18, 24, 30, and 36
measure: Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
timeFrame: Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)
measure: Change From Baseline in EQ-5D-5L
timeFrame: Baseline; up to Cycle 39 Day 1 (each cycle was comprised of 4 weeks)
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: from Baseline to LPLV (approximately 5 years)
measure: Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: AUClast of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: AUCinf of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: CL/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: Vz/F of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: Tmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: t1/2 of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
timeFrame: Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
measure: Utilization of Medical Resources
timeFrame: from Baseline to LPLV (approximately 5 years)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Incyte Investigative Site
state: Arizona
city: Duarte
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facility: Incyte Investigative Site
state: California
city: La Jolla
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city: Los Angeles
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facility: Incyte Investigative Site
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facility: Incyte Investigative Site
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facility: Incyte Investigative Site
state: Massachusetts
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facility: Incyte Investigative Site
state: Massachusetts
city: Omaha
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facility: Incyte Investigative Site
state: Nebraska
city: Hackensack
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facility: Incyte Investigative Site
state: New Jersey
city: New York
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facility: Incyte Investigative Site
state: New York
city: New York
country: United States
facility: Incyte Investigative Site
state: New York
city: New York
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facility: Incyte Investigative Site
state: New York
city: Chapel Hill
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facility: Incyte Investigative Site
state: North Carolina
city: Durham
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facility: Incyte Investigative Site
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city: Winston-Salem
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facility: Incyte Investigative Site
state: North Carolina
city: Cincinnati
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facility: Incyte Investigative Site
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city: Cleveland
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facility: Incyte Investigative Site
state: Ohio
city: Cleveland
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facility: Incyte Investigative Site
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city: Columbus
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facility: Incyte Investigative Site
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city: Oklahoma City
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facility: Incyte Investigative Site
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facility: Incyte Investigative Site
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city: Pittsburgh
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facility: Incyte Investigative Site
state: Pennsylvania
city: Pittsburgh
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facility: Incyte Investigative Site
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city: Nashville
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facility: Incyte Investigative Site
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facility: Incyte Investigative Site
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city: Milwaukee
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city: Leuven
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city: Liege
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city: Sofia
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Vancouver
country: Canada
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state: British Columbia
city: Hamilton
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state: Ontario
city: Ottawa
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state: Ontario
city: Toronto
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state: Ontario
city: Praha 2
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Hradec Kralove
country: Czechia
facility: Novartis Investigative Site
state: CZE
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Odense
country: Denmark
facility: Novartis Investigative Site
city: Bordeaux
country: France
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state: Aquitaine
city: Amiens cedex1
country: France
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city: Caen Cedex 9
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
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city: Limoges cedex
country: France
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city: Lyon Cedex 08
country: France
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country: France
facility: Novartis Investigative Site
city: PARIS Cedex 12
country: France
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city: Paris Cedex 19
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city: Pierre-Benite Cédex
country: France
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city: Mannheim
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country: Germany
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city: Bergamo
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city: Bologna
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state: BO
city: Brescia
country: Italy
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state: BS
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Genova
country: Italy
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state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Pescara
country: Italy
facility: Novartis Investigative Site
state: PE
city: Parma
country: Italy
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state: PR
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Udine
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city: Perugia
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country: Japan
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city: Fukuoka-city
country: Japan
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state: Fukuoka
city: Sapporo-city
country: Japan
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state: Hokkaido
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Nishinomiya-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Isehara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyō-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Okayama
country: Japan
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city: Amman
country: Jordan
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Gliwice
country: Poland
facility: Novartis Investigative Site
state: Slaskie
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Kraków
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigational Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Ponce
country: Puerto Rico
facility: Incyte Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigational Site
city: Bucharest
country: Romania
facility: Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucía
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: L'Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: El Palmar
country: Spain
facility: Novartis Investigative Site
state: Murica
city: San Sebastian
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Incyte Corporation
name: Rodica Morariu-Zamfir
role: STUDY_DIRECTOR
References:
citation: Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.
citation: Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.
citation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.