← Back to Search

Alkylating agents

Venetoclax + Obinutuzumab for Leukemia (CRISTALLO Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm
CLL requiring treatment according to the iwCLL criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of treatment response visit (up to approximately 15 months in arm ven + g and 9 months in arm fcr/br
Awards & highlights

CRISTALLO Trial Summary

This trial will compare the efficacy and safety of two different treatments for previously untreated CLL without DEL(17P) or TP53 mutation. One treatment group will receive venetoclax and obinutuzumab, and the other will receive fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include digestive issues, low blood cell counts leading to increased infection risk, fatigue, liver function abnormalities. There's also a chance of allergic reactions due to medication components.

CRISTALLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to either not have sex or use birth control, and not donate sperm.
Select...
My CLL condition requires treatment.
Select...
I am 18 years old or older.
Select...
I have chronic lymphocytic leukemia that has not been treated yet.
Select...
My white blood cell count is healthy, unless my bone marrow is affected.
Select...
My liver is functioning well, based on recent tests.
Select...
My overall health score is good and my kidneys are working well.

CRISTALLO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of treatment response visit (up to approximately 15 months in arm ven + g and 9 months in arm fcr/br
This trial's timeline: 3 weeks for screening, Varies for treatment, and at end of treatment response visit (up to approximately 15 months in arm ven + g and 9 months in arm fcr/br for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minimal Residual Disease (MRD) Response Rate Using Next-generation Sequencing (NGS)
Secondary outcome measures
Arm VEN + G: Reduction in Mandatory Hospitalisations During Venetoclax Ramp-up
Arm VEN + G: Tumor Lysis Syndrome (TLS) Risk Reduction Rate
Best Overall Response
+13 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

CRISTALLO Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,003 Total Patients Enrolled
Clinical trialStudy DirectorHoffmann-La Roche

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04285567 — Phase 3
Chronic Lymphocytic Leukemia Research Study Groups: FCR/BR, VEN + G
Chronic Lymphocytic Leukemia Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT04285567 — Phase 3
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04285567 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main illnesses that Venetoclax is used to treat?

"While it is used to treat dlbcl, Venetoclax has also shown efficacy in managing lung cancers, multiple sclerosis, and other b-cell lymphomas."

Answered by AI

What does the medical research say about Venetoclax's efficacy?

"As of now, there are 1461 ongoing studies involving Venetoclax with 260 of those being in Phase 3. Many of the research facilities are located in Philadelphia, however, there are 44687 total locations running trials for Venetoclax."

Answered by AI

Does this continent have a high number of test facilities for this clinical trial?

"Patients can enroll at Oncology Assoc of Oregon, PC in Eugene, Oregon, Texas Oncology-Denton South in Denton, Tennessee, and Texas Oncology, P.A. - Tyler; Tyler Cancer Center in Austin, Colorado. There are also 10 other sites."

Answered by AI

What is the potential for Venetoclax to cause harm?

"Venetoclax has been classified as a 3 in terms of safety. This designation comes from being a Phase 3 trial, where there is both some efficacy data and multiple rounds of safety data."

Answered by AI

How many patients are being asked to participate in this clinical research?

"165 patients that fit the bill are necessary to carry out this research project sponsored by Hoffmann-La Roche. The trial will be conducted at various locations, with Oncology Assoc of Oregon, PC in Eugene, Oregon and Texas Oncology-Denton South in Denton, Tennessee being two of the sites."

Answered by AI

Are new participants currently being enrolled in this experiment?

"That is correct, the online information does show that the study is actively looking for 165 individuals from 10 different locations. The original posting was on May 28th, 2020, with the most recent update on November 3rd, 2022."

Answered by AI
~34 spots leftby Mar 2025