A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT04285567
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Obinutuzumab 1000 milligrams (mg) will be administered IV on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
  • Venetoclax — DRUG
    Venetoclax 20 mg will be administered orally, once daily starting on Day 22 of Cycle 1 for 7 days, then ramp up from 50 to 400 mg/day during Cycle 2 and continue at 400 mg/day from Day 1 of Cycle 3 till end of Cycle 12.
  • Fludarabine — DRUG
    Fludarabine will be administered in a dosage of 25 milligram per meter squared (mg/m\^2), IV, on days 1, 2, and 3 of Cycles 1-6.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered in a dosage of 250 mg/m\^2, IV, on Days 1, 2, and 3 Cycles 1-6.
  • Rituximab — DRUG
    Rituximab will be administered at a dose of 375 mg/m\^2, IV, on Cycle 1, Day 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.
  • Bendamustine — DRUG
    Bendamustine will be administered at a dose of 90 mg/m\^2, IV, on 2 consecutive days of Cycles 1-6.

Study Details

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

Key Dates

Start date
May 28, 2020
Status verified
Feb 2026
Primary completion
Mar 19, 2024
Completion
Mar 19, 2025

Study Design

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

Arms

  • Experimental: VEN + G
    Participants will receive 12 cycles of treatment (each cycle is 28 days). Venetoclax (VEN) will be administered orally, daily, with a 5-week ramp-up period, starting on Cycle 1, Day 22 and administration will continue until the end of Cycle 12. Obinutuzumab (G) will be administered intravenously (IV) on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
  • Active Comparator: FCR/BR
    Participants will receive 6 cycles of Fludarabine + Cyclophosphamide + Rituximab (FCR) consisting of a single cycle of a single infusion of rituximab on Day 1 and fludarabine and cyclophosphamide infusions on Days 1-3 of each 28-day cycle or bendamustine (B) as infusions on Days 1 and 2 and a single cycle of rituximab on Day 1 of each 28-day cycle.

Primary Outcome Measure

Minimal Residual Disease (MRD) Response Rate Measured in Peripheral Blood (PB) Using Next Generation Sequencing (NGS) [ Time Frame: At Month 15 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Medical Center of AuroraAuroraColorado80012-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
University of Tennessee Medical Center;Office of Clinical TrialsKnoxvilleTennessee37920-
Oncology & Hematology Associates of Southwest Virginia, Inc._GoldschmidtRoanokeVirginia24014-

Find similar trials in Aurora, CO

By research site
Medical Center of Aurora· Aurora, COAmerican Oncology Partners of Maryland, PA· Bethesda, MDUniversity of Tennessee Medical Center;Office of Clinical Trials· Knoxville, TNOncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt· Roanoke, VA

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