Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
NCT ID: NCT02959944
Last Updated: 2023-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2017-05-11
2021-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ibrutinib + Prednisone
Ibrutinib (420 mg) given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity. The 420 mg dose was adjusted for cytochrome P450 \[CYP\] inhibitors or hepatic dysfunction as applicable.
Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses.
ibrutinib
Ibrutinib capsules administered orally daily
Prednisone
Prednisone administered daily
Placebo + Prednisone
Placebo given orally once daily continuously starting on Week 1 Day 1 until cGVHD progression, progression of underlying malignancy, participant begins another systemic treatment for cGVHD or unacceptable toxicity.
Prednisone 1 mg/kg/d given orally once daily continuously starting on Week 1 Day 1 until unacceptable toxicity or until participant is successfully tapered from the prednisone. Starting prednisone dose may be as low as 0.5 mg/kg/d if a participant cannot tolerate higher doses.
Placebo
Placebo capsules administered orally daily
Prednisone
Prednisone administered daily
Interventions
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ibrutinib
Ibrutinib capsules administered orally daily
Placebo
Placebo capsules administered orally daily
Prednisone
Prednisone administered daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Need for systemic treatment with corticosteroids for cGVHD
* No previous systemic treatment for cGVHD (including extracorporeal photopheresis \[ECP\])
* Participants may be receiving other immunosuppressants for the prophylaxis or treatment of acute GVHD but if the subject is receiving prednisone for prophylaxis or treatment of acute GVHD it must be at or below 0.5 mg/kg/d
* Age ≥12 years old
* Karnofsky or Lansky (subjects \<16 years) performance status ≥60
Exclusion Criteria
* Inability to begin a prednisone dose ≥0.5 mg/kg/d for the treatment of cGVHD
* Any uncontrolled infection or active infection requiring ongoing systemic treatment
* Progressive underlying malignant disease or any post-transplant lymphoproliferative disease
* Known bleeding disorders
* Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
12 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Justin Wahlstrom, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120
Scottsdale, Arizona, United States
LPCH Stanford /ID# 1140-1128
Palo Alto, California, United States
Ucsf /Id# 1140-0003
San Francisco, California, United States
Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400
Stanford, California, United States
UCHSC Anschultz Cancer Pavilion /ID# 1140-0068
Aurora, Colorado, United States
Children's National Medical Center /ID# 1140-1122
Washington D.C., District of Columbia, United States
Jackson Memorial Hospital, University of Miami /ID# 1140-0647
Miami, Florida, United States
Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121
Orlando, Florida, United States
Emory University, Winship Cancer Institute /ID# 1140-0033
Atlanta, Georgia, United States
Emory University/Winship Cancer Institute /ID# 1140-1179
Atlanta, Georgia, United States
University of Chicago /ID# 1140-0126
Chicago, Illinois, United States
Loyola University /ID# 1140-0713
Maywood, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010
Indianapolis, Indiana, United States
University of Kentucky /ID# 1140-1140
Lexington, Kentucky, United States
University of Louisville Hospital /ID# 1140-1131
Louisville, Kentucky, United States
University of Maryland /ID# 1140-0205
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center /ID# 1140-0020
Boston, Massachusetts, United States
Boston Childrens Hospital /ID# 1140-1615
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 1140-0349
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer In /ID# 1140-0130
Detroit, Michigan, United States
University of Minnesota /ID# 1140-0807
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, MN /ID# 1140-0240
Rochester, Minnesota, United States
Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343
Hackensack, New Jersey, United States
Rutgers Cancer Institute of NJ /ID# 1140-0803
New Brunswick, New Jersey, United States
New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200
New York, New York, United States
Stony Brook University Medical Center /ID# 1140-0719
New York, New York, United States
Columbia University Medical Center, MS-CHONY /ID# 1140-1124
New York, New York, United States
Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019
New York, New York, United States
University of Rochester Cancer Center /ID# 1140-0127
Rochester, New York, United States
Montefiore Medical Center - Moses Campus /ID# 1140-0120
The Bronx, New York, United States
University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133
Chapel Hill, North Carolina, United States
Univ Hosp Cleveland /ID# 1140-0941
Cleveland, Ohio, United States
University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, MUSC /ID# 1140-0738
Charleston, South Carolina, United States
Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024
Nashville, Tennessee, United States
Methodist San Antonio /ID# 1140-1118
San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center /ID# 1140-0404
Seattle, Washington, United States
West Virginia University /ID# 1140-1090
Morgantown, West Virginia, United States
The Kinghorn Cancer Centre /ID# 1140-1165
Darlinghurst, New South Wales, Australia
Westmead Hospital /ID# 1140-0848
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital /ID# 1140-0190
Herston, Queensland, Australia
Royal Children's Hospital/ID# 1140-1154
Parkville, Victoria, Australia
Royal Melbourne Hospital (RMH) /ID# 1140-0633
Parkville, Victoria, Australia
Fiona Stanley Hospital /ID# 1140-0880
Perth, Western Australia, Australia
Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373
Graz, , Austria
Krankenhaus der Elisabethinen Linz /ID# 1140-0849
Linz, , Austria
University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166
Vancouver, British Columbia, Canada
The Ottawa Hospital Regional Cancer Center /ID# 1140-0159
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre /ID# 1140-0043
Toronto, Ontario, Canada
CHU Sainte-Justine /ID# 1140-1143
Montreal, Quebec, Canada
The First Affiliated Hospital of Soochow University /ID# 1140-1208
Suzhou, Jiangsu, China
Chinese PLA General Hospital /ID# 1140-1198
Beijing, , China
Nanfang Hospital /ID# 1140-1379
Guangzhou, , China
UHC Zagreb /ID# 1140-1169
Zagreb, , Croatia
Hopital de Brabois /ID# 1140-0775
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Amiens Groupe hospitalier Sud /ID# 1140-1205
Amiens, , France
CHU de GRENOBLE Alpes /ID# 1140-1058
Grenoble, , France
Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750
Lille, , France
CHU de Nantes /ID# 1140-0520
Nantes, , France
Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918
Paris, , France
Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735
Paris, Île-de-France Region, France
Robert Bosch Hospital /ID# 1140-1160
Stuttgart, Baden-Wurttemberg, Germany
Universitatsklinikum Munster /ID# 1140-1195
Munster, Lower Saxony, Germany
Universitaetsklinikum Dresden /ID# 1140-1367
Dresden, , Germany
Hannover Medical School /ID# 1140-1141
Hanover, , Germany
Dr. Haunerschen Kinderspital /ID# 1140-1142
Munich, , Germany
University Hospital of Regensburg /ID# 1140-1446
Regensburg, , Germany
St. Laszlo Hospital /ID# 1140-1164
Budapest, , Hungary
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150
Rome, Lazio, Italy
A.O. Univ. Ospedali Riuniti /ID# 1140-0932
Ancona, The Marches, Italy
ASST Papa Giovanni XXIII /ID# 1140-1231
Bergamo, , Italy
Ospedale San Raffaele IRCCS /ID# 1140-0523
Milan, , Italy
University of Torino /ID# 1140-1268
Torino, , Italy
Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156
Turin, , Italy
Anjou Kousei Hospital /ID# 1140-1435
Anjo, Aichi-ken, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437
Hiroshima, Hiroshima, Japan
Kobe City Medical Center General Hospital /ID# 1140-1438
Kobe, Hyōgo, Japan
Hyogo College of Medicine College Hospital /Id# 1140-1434
Nishinomiya-shi, Hyōgo, Japan
Duplicate_University of Tsukuba Hospital /ID# 1140-1445
Tsukuba, Ibaraki, Japan
Tokai University Hospital /ID# 1140-1444
Isehara-shi, Kanagawa, Japan
Duplicate_Kurashiki Central Hospital /ID# 1140-1442
Kurishiki-shi, Okayama-ken, Japan
Okayama University Hospital /ID# 1140-1430
Okayama, Okayama-ken, Japan
Osaka Women's and Children's Hospital /ID# 1140-1440
Izumi-Shi, Osaka, Japan
Osaka City University Hospital /ID# 1140-1157
Osaka, Osaka, Japan
Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development /ID# 1140-1443
Setagaya-ku, Tokyo, Japan
Kumamoto Medical Center /ID# 1140-1431
Kumamoto, , Japan
Hokkaido University Hospital /ID# 1140-1436
Sapporo, , Japan
National University Cancer Institute - National University Health System /ID# 1140-1155
Singapore, , Singapore
Singapore General Hospital /ID# 1140-1162
Singapore, , Singapore
Kyungpook National Univ Hosp /ID# 1140-1153
Daegu, Daegu Gwang Yeogsi, South Korea
Yonsei University Health System, Severance Hospital /ID# 1140-0927
Seodaemun-gu, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 1140-0925
Seoul, Seoul Teugbyeolsi, South Korea
Cath Univ Seoul St Mary's Hosp /ID# 1140-0928
Seoul, Seoul Teugbyeolsi, South Korea
SoonChunHyang University Seoul /ID# 1140-1163
Seoul, , South Korea
Asan Medical Center /ID# 1140-0963
Seoul, , South Korea
Hospital Clinic /ID# 1140-0533
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 1140-0535
Barcelona, , Spain
Hospital Universitario Virgen del Rocio /ID# 1140-0863
Seville, , Spain
Hospital Clinico Universitario de Valencia /ID# 1140-1145
Valencia, , Spain
China Medical University Hosp /ID# 1140-1199
Taichung, Taichung, Taiwan
National Taiwan Univ Hosp /ID# 1140-1184
Taipei City, Taipei, Taiwan
Countries
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References
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Miklos DB, Abu Zaid M, Cooney JP, Albring JC, Flowers M, Skarbnik AP, Yakoub-Agha I, Ko BS, Bruno B, Waller EK, Yared J, Sohn SK, Bulabois CE, Teshima T, Jacobsohn D, Greinix H, Mokatrin A, Lee Y, Wahlstrom JT, Styles L, Socie G. Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study. J Clin Oncol. 2023 Apr 1;41(10):1876-1887. doi: 10.1200/JCO.22.00509. Epub 2023 Jan 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCYC-1140-IM
Identifier Type: -
Identifier Source: org_study_id
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