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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02401048
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Jun 2019
Primary completion
Nov 30, 2017
Completion
Nov 30, 2017

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1b/2 : Overall Response Rate of Number of Participants [ Time Frame: From the date of first study treatment until progressive disease ]

Locations (11)

FacilityCityStateZIPSite coordinators
Site-0397BirminghamAlabama35294-
Site-0047DuarteCalifornia91010-
Site-0038StanfordCalifornia94305-
Site-0388MiamiFlorida33136-
Site-0126ChicagoIllinois60637-
Site-0020/0173BostonMassachusetts02114-
Site-0729Ann ArborMichigan48109-
Site-0130DetroitMichigan48201-
Site-0343HackensackNew Jersey07601-
Site-0402PhiladelphiaPennsylvania19104-
Site-0114SeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
Site-0397· Birmingham, ALSite-0047· Duarte, CASite-0038· Stanford, CASite-0388· Miami, FLSite-0126· Chicago, ILSite-0020/0173· Boston, MA

Related Studies