Venetoclax + Obinutuzumab for Leukemia
(CRISTALLO Trial)

Recruiting in Palo Alto (17 mi)

+90 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Clinical trial

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults over 18 with untreated Chronic Lymphocytic Leukemia (CLL) who are fit (CIRS score ≤6, creatinine clearance ≥70 mL/min), and have a life expectancy of more than 6 months. They must not be pregnant or nursing, agree to use contraception, and should not have certain infections or recent drug treatments that could interfere with the study.

Inclusion Criteria

I agree to either not have sex or use birth control, and not donate sperm.

Ability to comply with the study protocol, in the investigator's judgment

My CLL condition requires treatment.

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Exclusion Criteria

I haven't taken steroids for cancer treatment in the last 7 days, except for asthma or topical uses.

My cancer has spread to my brain or spinal cord.

You have a history of using illegal drugs or abusing alcohol in the past year, according to the judgment of the researcher.

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Treatment Details

Interventions

Bendamustine (Alkylating agents)
Cyclophosphamide (Alkylating agents)
Fludarabine (Nucleoside analogues)
Obinutuzumab (Monoclonal Antibodies)
Rituximab (Monoclonal Antibodies)
Venetoclax (B-cell lymphoma-2 (BCL-2) inhibitor)

Trial OverviewThe trial compares Venetoclax plus Obinutuzumab against Fludarabine, Cyclophosphamide plus Rituximab or Bendamustine plus Rituximab in treating CLL. Participants will be randomly assigned to one of these two treatment groups to assess effectiveness and safety.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: VEN + GExperimental Treatment2 Interventions

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.

Group II: FCR/BRActive Control4 Interventions

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.

Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Treanda for: