A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
NCT ID: NCT02401048
Last Updated: 2019-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2015-05-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Phase 1b/ 2: Follicular lymphoma expansion cohort
In 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.
Ibrutinib
MEDI4736
Phase 1b/ 2: Diffuse large B-cell lymphoma expansion cohort
In 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.
Ibrutinib
MEDI4736
Interventions
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Ibrutinib
MEDI4736
Eligibility Criteria
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Inclusion Criteria
* Measurable disease sites on CT scan (\>1.5 cm in longest dimension)
* Adequate hematologic function:
1. Absolute Neutrophil Count \>1500 cells/mm3
2. Platelets \>50000 cells/mm3
3. Hemoglobin \>8.0 g/dL
* Adequate hepatic and renal function:
1. AST or ALT ≤2.5 x ULN
2. Bilirubin ≤1.5 x ULN
3. Estimated creatinine clearance (Cockcroft-Gault) \>40 mL/min
* ECOG 0 or 1
Exclusion Criteria
* Requires treatment or prophylaxis with a strong cytochrome P450 (CYP) 3A inhibitor
* Primary CNS lymphoma or evidence of CNS involvement by lymphoma
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Emily Liu
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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Site-0397
Birmingham, Alabama, United States
Site-0047
Duarte, California, United States
Site-0038
Stanford, California, United States
Site-0388
Miami, Florida, United States
Site-0126
Chicago, Illinois, United States
Site-0020/0173
Boston, Massachusetts, United States
Site-0729
Ann Arbor, Michigan, United States
Site-0130
Detroit, Michigan, United States
Site-0343
Hackensack, New Jersey, United States
Site-0402
Philadelphia, Pennsylvania, United States
Site-0114
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCYC-1136-CA
Identifier Type: -
Identifier Source: org_study_id
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