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Venetoclax + Obinutuzumab for Leukemia (CRISTALLO Trial)
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.
CRISTALLO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCRISTALLO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471CRISTALLO Trial Design
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Who is running the clinical trial?
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- 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.I haven't taken any specific medications in the last 28 days.I agree to either not have sex or use birth control, and not donate sperm.I am currently undergoing or have completed radiotherapy.My health issues do not limit my ability to receive this trial's treatment, except for problems with my eyes, ears, nose, or throat.I have received treatments for lymphoma or leukemia.I have been diagnosed with Small Lymphocytic Lymphoma (SLL) only.My CLL condition requires treatment.I do not have HIV or HTLV-1.My test shows I have a del(17p) or TP53 mutation.I have had progressive multifocal leukoencephalopathy in the past.I have had cancer before.I haven't had a severe infection needing IV treatment in the last 8 weeks.I am currently undergoing hormone therapy.I haven't taken strong or moderate CYP3A affecting drugs in the last week.I am 18 years old or older.You have difficulty swallowing many pills.I have chronic lymphocytic leukemia that has not been treated yet.My white blood cell count is healthy, unless my bone marrow is affected.I have taken specific medications for my condition.You are allergic to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, venetoclax, or any of the ingredients in these medications.I do not have any active or uncontrolled infections.You are expected to live for at least 6 more months.My CLL has transformed into a more aggressive form of lymphoma.I am currently receiving or have received immunotherapy.My liver is functioning well, based on recent tests.My overall health score is good and my kidneys are working well.I have not received a live vaccine in the last 28 days.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I have an uncontrolled autoimmune blood condition.You have had serious allergic reactions to certain types of medicines made from human or animal sources.
- Group 1: FCR/BR
- Group 2: VEN + G
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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