166 Participants Needed

Venetoclax + Obinutuzumab for Leukemia

(CRISTALLO Trial)

Recruiting at 90 trial locations
RS
RS
Overseen ByReference Study ID Number: CO41685 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken certain therapies for lymphoma/leukemia, strong CYP3A inhibitors/inducers, or consumed grapefruit products shortly before starting the trial.

What makes the drug combination of Venetoclax and Obinutuzumab unique for treating leukemia?

The combination of Venetoclax and Obinutuzumab is unique because it offers a chemotherapy-free, fixed-duration treatment option for chronic lymphocytic leukemia (CLL), particularly for patients who are not fit for intensive chemoimmunotherapy. This regimen has shown significantly longer progression-free survival and higher rates of undetectable minimal residual disease compared to traditional chemoimmunotherapy with chlorambucil and obinutuzumab.12345

What data supports the effectiveness of the drug Venetoclax + Obinutuzumab for Leukemia?

Research shows that Venetoclax combined with Obinutuzumab significantly improves progression-free survival in patients with chronic lymphocytic leukemia (CLL) compared to traditional chemoimmunotherapy. This combination also leads to higher rates of complete response and undetectable minimal residual disease, making it an important treatment option for CLL.23567

Who Is on the Research Team?

Ct

Clinical trial

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.
See 8 more

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.
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either VEN + G for 12 cycles or FCR/BR for 6 cycles

VEN + G: 12 months, FCR/BR: 6 months
Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 74 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bendamustine
  • Cyclophosphamide
  • Fludarabine
  • Obinutuzumab
  • Rituximab
  • Venetoclax
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: VEN + GExperimental Treatment2 Interventions
Group II: FCR/BRActive Control4 Interventions

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

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Approved in United States as Treanda for:
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Approved in European Union as Ribomustin for:
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Approved in Canada as Levact for:
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Approved in Japan as Bendamustine hydrochloride for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

In the phase III CLL14 trial, a 12-month treatment with venetoclax combined with obinutuzumab significantly improved progression-free survival and rates of undetectable minimal residual disease compared to traditional chemoimmunotherapy with chlorambucil and obinutuzumab in patients with untreated chronic lymphocytic leukaemia.
Venetoclax + obinutuzumab is a well-tolerated, chemotherapy-free treatment option for CLL, with manageable side effects like neutropenia, making it suitable for patients who cannot undergo intensive chemotherapy.
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia.Blair, HA.[2021]
The combination of venetoclax with bendamustine-rituximab (BR) was found to be safe and tolerable in a study of 60 patients with relapsed/refractory non-Hodgkin's lymphoma, with the recommended phase II dose established at 800 mg daily.
The overall response rate to the treatment was 65%, with a median duration of response of 38.3 months, indicating preliminary efficacy for this combination therapy in managing B-cell NHL.
Venetoclax, bendamustine, and rituximab in patients with relapsed or refractory NHL: a phase Ib dose-finding study.de Vos, S., Swinnen, LJ., Wang, D., et al.[2021]
Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.
While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia .Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]

Citations

Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. [2021]
Venetoclax, bendamustine, and rituximab in patients with relapsed or refractory NHL: a phase Ib dose-finding study. [2021]
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study. [2023]
Pharmacokinetics and Exposure-Response Analysis of Venetoclax + Obinutuzumab in Chronic Lymphocytic Leukemia: Phase 1b Study and Phase 3 CLL14 Trial. [2022]
Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial. [2020]
Venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (HOVON 139/GiVe): primary endpoint analysis of a multicentre, open-label, randomised, parallel-group, phase 2 trial. [2022]
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