Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02959944
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ibrutinib — DRUG
    Ibrutinib capsules administered orally daily
  • Placebo — DRUG
    Placebo capsules administered orally daily
  • Prednisone — DRUG
    Prednisone administered daily

Study Details

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Key Dates

Start date
May 11, 2017
Status verified
Mar 2023
Primary completion
Mar 27, 2020
Completion
Jul 12, 2021

Study Design

Enrollment
193 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Primary Analysis: Response Rate at 48 Weeks [ Time Frame: 48 weeks (Cumulatively up to 30 March 2020) ]

Locations (38)

FacilityCityStateZIPSite coordinators
Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120ScottsdaleArizona85258-4547-
LPCH Stanford /ID# 1140-1128Palo AltoCalifornia94304-
Ucsf /Id# 1140-0003San FranciscoCalifornia94143-
Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400StanfordCalifornia94305-
UCHSC Anschultz Cancer Pavilion /ID# 1140-0068AuroraColorado80010-
Children's National Medical Center /ID# 1140-1122Washington D.C.District of Columbia20010-
Jackson Memorial Hospital, University of Miami /ID# 1140-0647MiamiFlorida33136-1096-
Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121OrlandoFlorida32804-
Emory University, Winship Cancer Institute /ID# 1140-0033AtlantaGeorgia30322-
Emory University/Winship Cancer Institute /ID# 1140-1179AtlantaGeorgia30322-
University of Chicago /ID# 1140-0126ChicagoIllinois60637-
Loyola University /ID# 1140-0713MaywoodIllinois60153-
Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010IndianapolisIndiana46202-5112-
University of Kentucky /ID# 1140-1140LexingtonKentucky40508-2678-
University of Louisville Hospital /ID# 1140-1131LouisvilleKentucky40202-
University of Maryland /ID# 1140-0205BaltimoreMaryland21201-
Boston Childrens Hospital /ID# 1140-1615BostonMassachusetts02115-
Dana-Farber Cancer Institute /ID# 1140-0349BostonMassachusetts02215-
Massachusetts General Hospital Cancer Center /ID# 1140-0020BostonMassachusetts02114-
Barbara Ann Karmanos Cancer In /ID# 1140-0130DetroitMichigan48201-
University of Minnesota /ID# 1140-0807MinneapolisMinnesota55455-
Mayo Clinic, Rochester, MN /ID# 1140-0240RochesterMinnesota55905-
Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343HackensackNew Jersey07601-
Rutgers Cancer Institute of NJ /ID# 1140-0803New BrunswickNew Jersey08903-
Columbia University Medical Center, MS-CHONY /ID# 1140-1124New YorkNew York10032-1559-
New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200New YorkNew York10021-
Stony Brook University Medical Center /ID# 1140-0719New YorkNew York10021-
Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019New YorkNew York10065-
University of Rochester Cancer Center /ID# 1140-0127RochesterNew York14642-0001-
Montefiore Medical Center - Moses Campus /ID# 1140-0120The BronxNew York10467-
University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133Chapel HillNorth Carolina27516-
Univ Hosp Cleveland /ID# 1140-0941ClevelandOhio44106-
University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050PittsburghPennsylvania15232-
Medical University of South Carolina, MUSC /ID# 1140-0738CharlestonSouth Carolina29425-
Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024NashvilleTennessee37232-5280-
Methodist San Antonio /ID# 1140-1118San AntonioTexas78229-3710-
Fred Hutchinson Cancer Research Center /ID# 1140-0404SeattleWashington98109-
West Virginia University /ID# 1140-1090MorgantownWest Virginia26506-

Find similar trials in Scottsdale, AZ

By research site
Arizona Oncology - Scottsdale - Cancer Transplant Institute Location· Scottsdale, AZLPCH Stanford· Palo Alto, CAUcsf· San Francisco, CAStanford University/Stanford Cancer Center, Pasteur Drive· Stanford, CAUCHSC Anschultz Cancer Pavilion· Aurora, COChildren's National Medical Center· Washington D.C., DC

Related Studies