A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
A Multi-Center Open-Label Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With MEDI4736, in Subjects With Relapsed or Refractory Lymphomas
1 other identifier
interventional
61
1 country
11
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of the combination treatment of ibrutinib and MEDI4736 in subjects with relapsed or refractory lymphomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2015
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedResults Posted
Study results publicly available
June 27, 2019
CompletedJune 27, 2019
June 1, 2019
2.5 years
March 4, 2015
November 16, 2018
June 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Phase 1b/2 : Overall Response Rate of Number of Participants
The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014).
From the date of first study treatment until progressive disease
Secondary Outcomes (14)
Phase 1b/ 2: Duration of Response
Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first.
Phase 1b/ 2: Progression-free Survival (PFS)
first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression
Phase 1b/2: Overall Survival
First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause
Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib
Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)
Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib
Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)
- +9 more secondary outcomes
Study Arms (2)
Phase 1b/ 2: Follicular lymphoma expansion cohort
EXPERIMENTALIn the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose.
Phase 1b/ 2: Diffuse large B-cell lymphoma expansion cohort
EXPERIMENTALIn the Phase 1b (safety portion) of the study, a starting dose of 560 mg of ibrutinib and 10 mg/kg of MEDI4736 explored in cohort 1 and followed a 6+3 dose de-escalation design. Phase 2 used the phase 1b starting dose.
Interventions
Eligibility Criteria
You may qualify if:
- Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
- Measurable disease sites on CT scan (\>1.5 cm in longest dimension)
- Adequate hematologic function:
- Absolute Neutrophil Count \>1500 cells/mm3
- Platelets \>50000 cells/mm3
- Hemoglobin \>8.0 g/dL
- Adequate hepatic and renal function:
- AST or ALT ≤2.5 x ULN
- Bilirubin ≤1.5 x ULN
- Estimated creatinine clearance (Cockcroft-Gault) \>40 mL/min
- ECOG 0 or 1
You may not qualify if:
- Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody
- Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
- Primary CNS lymphoma or evidence of CNS involvement by lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacyclics LLC.lead
- AstraZenecacollaborator
- Janssen Research & Development, LLCcollaborator
Study Sites (11)
Site-0397
Birmingham, Alabama, 35294, United States
Site-0047
Duarte, California, 91010, United States
Site-0038
Stanford, California, 94305, United States
Site-0388
Miami, Florida, 33136, United States
Site-0126
Chicago, Illinois, 60637, United States
Site-0020/0173
Boston, Massachusetts, 02114, United States
Site-0729
Ann Arbor, Michigan, 48109, United States
Site-0130
Detroit, Michigan, 48201, United States
Site-0343
Hackensack, New Jersey, 07601, United States
Site-0402
Philadelphia, Pennsylvania, 19104, United States
Site-0114
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Liu
- Organization
- Pharmacyclics
Study Officials
- STUDY DIRECTOR
Emily Liu
Pharmacyclics LLC.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 27, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
June 27, 2019
Results First Posted
June 27, 2019
Record last verified: 2019-06