A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Part of paid clinical trials in La Jolla, California.

Sponsor
Celgene
Study ID
NCT02406742
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • CC-122 — DRUG
    CC-122 will be administered daily starting at Cycle 1 Day 1 in 28-day cycles until disease progression, unacceptable toxicity, or discontinuation for any other reason.
  • Ibrutinib — DRUG
  • Obinutuzumab — DRUG
    Obinutuzumab will be administered as an intravenous (IV) infusion at a dose of 100 mg on Cycle 1 Day 1 and 900 mg on Cycle 1 Day 2 and 1000 mg on Cycle 1 Days 8 and 15. The dose of obinutuzumab on Days 1 and 2 of Cycle 1 may be adjusted per institutional practice as long as the combined dose equals 1000 mg. Obinutuzumab will be administered at a dose of 1000 mg on Day 1 of Cycles 2 through 6.

Study Details

Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience.

Key Dates

Start date
Jul 27, 2015
Status verified
Aug 2021
Primary completion
Jul 7, 2020
Completion
Jul 7, 2020

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-122 Single Agent
    An intrasubject dose escalation design was selected to determine the safety of single agent CC-122 (Arm A) in order to reach an optimal, clinically active dose and to mitigate the risk of early tumor flare reactions, based on earlier experience with lenalidomide monotherapy in CLL.
  • Experimental: CC-122 in combination with ibrutinib
    Ascending fixed dose cohorts evaluated in a 3 + 3 dose-finding design will be used to determine the safety and tolerability of the combination of CC-122 and ibrutinib to determine the NTD, MTD, and Recommended Phase 2 Dose (RP2D). An intrasubject dose escalation cohort may also be evaluated at the discretion of the Safety Review Committee. The RP2D of the combination may be evaluated in ibrutinib-naïve and high-risk CLL patients in the dose expansion phase to continue to evalute safety and efficacy.
  • Experimental: CC-122 in combination with obinutuzumab
    Ascending fixed dose cohorts evaluated in a 3 + 3 dose-finding design will be used to determine the safety and tolerability of the combination of CC-122 and obinutuzumab to determine the , MTD, and Recommended Phase 2 Dose (RP2D). An intrasubject dose escalation cohort may also be evaluated at the discretion of the Safety Review Committee.. The RP2D of the combination may be evaluated in CLL patients who failed a B-cell receptor pathway inhibitor or venetoclax in the dose expansion phase to continue to evalute safety and efficacy.

Primary Outcome Measure

Number of Participants and Severity of AEs [ Time Frame: Approximately 60 Months ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Hackensack University Medical CenterHackensackNew Jersey07601-
Weill Cornell Medical College Dr. Feldman's OfficeNew YorkNew York10065-
Ohio State University Medical CenterJames Cancer HospitalColumbusOhio43210-
The West ClinicMemphisTennessee38120-
MD Anderson Cancer Center The University of TexasHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98118-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CADana Farber Cancer Institute· Boston, MAHackensack University Medical Center· Hackensack, NJWeill Cornell Medical College Dr. Feldman's Office· New York, NYOhio State University Medical CenterJames Cancer Hospital· Columbus, OHThe West Clinic· Memphis, TN

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