A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas

Pharmacyclics LLC.61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B-Cell Lymphoma Follicular Lymphoma

Interventions

IbrutinibDRUG

MEDI4736DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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: 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: * 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

Locations (11)

Site-0397

Birmingham, Alabama, United States

Site-0047

Duarte, California, United States

Site-0038

Stanford, California, United States

Site-0388

Outcomes

Primary Outcomes

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).

Time frame: From the date of first study treatment until progressive disease

Secondary Outcomes

Phase 1b/ 2: Duration of Response

Time frame: 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)

Time frame: first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression

Phase 1b/2: Overall Survival

Time frame: 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

Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)

Time frame: 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

Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)

Time frame: Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)

Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib

Data from ClinicalTrials.gov

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