A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02537613
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Obinutuzumab given weekly during cycle 1, then monthly during cycles 2-6
  • Ibrutinib — DRUG
    Ibrutinib given once daily by mouth

Study Details

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

Key Dates

Start date
Dec 31, 2015
Status verified
Mar 2026
Primary completion
Mar 31, 2020
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Arm A- obinutuzumab -> ibrutinib
    Participants enrolled in Arm A will receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6. Participants will begin to take ibrutinib daily starting cycle 2 and will continue with daily ibrutinib until the end of treatment.
  • Experimental: Arm B- ibrutinib -> obinutuzumab
    Participants enrolled in Arm B will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. Participants will begin to receive obinutuzumab weekly starting cycle 2, and will receive obinutuzumab monthly during cycles 3-7
  • Experimental: Arm C- obinutuzumab/ibrutinib
    Participants enrolled in Arm C will begin to take ibrutinib daily starting cycle 1 and will continue with daily ibrutinib until the end of treatment. At the same time, participants will begin to receive obinutuzumab weekly starting cycle 1, and will receive obinutuzumab monthly during cycles 2-6.

Primary Outcome Measure

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Baseline to 6 Months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Rochester Wilmot Cancer Inst.RochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Boston, MA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Rochester Wilmot Cancer Inst.· Rochester, NYDuke University Medical Center· Durham, NC

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