A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03462719
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.
  • Venetoclax — DRUG
    Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.
  • Chlorambucil — DRUG
    Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.
  • Obinutuzumab — DRUG
    Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.
  • Ibrutinib (as Subsequent Therapy) — DRUG
    Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.

Study Details

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Key Dates

Start date
Apr 17, 2018
Status verified
Jun 2026
Primary completion
Feb 26, 2021
Completion
Apr 5, 2029

Study Design

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

Arms

  • Experimental: Treatment Arm A: Ibrutinib and Venetoclax (I+VEN)
    Participants will initially receive ibrutinib (420 mg \[milligrams\]/day) for 3 cycles. Venetoclax dose ramp up (from 20 to 400 mg over 5 weeks) will begin at Cycle 4 and the combination of ibrutinib and venetoclax will be given for 12 cycles (each cycle is equivalent to 28 days). Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.
  • Active Comparator: Treatment Arm B: Chlorambucil and Obinutuzumab (G-Clb)
    Participants will receive chlorambucil and obinutuzumab (G-Clb) for 6 cycles. Participants will receive obinutuzumab, 1000 mg intravenously (IV) on Days 1, 8 and 15 of Cycle 1, and on Day 1 of Cycles 2 to 6 and chlorambucil 0.5 milligrams per kilogram (mg/kg) body weight, on Days 1 and 15 of Cycles 1 to 6. Participants who subsequently develop progressive disease may enter to Subsequent Therapy Phase to receive single-agent ibrutinib until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 2 years 10 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Norton Cancer InstituteLouisvilleKentucky40207-
John Theurer Cancer CenterHackensackNew Jersey07601-
Novant HealthCharlotteNorth Carolina28204-

Find similar trials in Louisville, KY

By research site
Norton Cancer Institute· Louisville, KYJohn Theurer Cancer Center· Hackensack, NJNovant Health· Charlotte, NC

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