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Corticosteroid
Rituximab + HDMP Debulking Before Venetoclax for Chronic B-Cell Leukemia
Phase 1
Waitlist Available
Led By Choi Michael, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential must agree to not become pregnant for the duration of the study
Patients must be age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is looking at whether giving high dose methylprednisolone with rituximab before starting venetoclax can reduce the amount of cancer cells and make it safer to take venetoclax.
Who is the study for?
Adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have had at least one prior treatment but not venetoclax in the last 6 months, can join. They must be generally healthy, understand the study, and agree to use contraception. Excluded are those with severe allergies to monoclonal antibodies, recent heart attacks, uncontrolled infections or other cancers that could interfere.Check my eligibility
What is being tested?
The trial tests if rituximab combined with high-dose methylprednisolone (HDMP) can reduce cancer cells before starting venetoclax for CLL/SLL patients. Depending on their risk of tumor lysis syndrome (TLS), participants will either receive HDMP/rituximab first or start directly on venetoclax. The goal is to see if this reduces TLS risk when beginning venetoclax therapy.See study design
What are the potential side effects?
Possible side effects include kidney problems or abnormal heart rhythms due to rapid cancer cell breakdown (TLS). Other risks may involve reactions related to infusion treatments and the individual drugs' typical side effects like immune system impacts and organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to become pregnant during the study.
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I am 18 years old or older.
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My cancer is classified as medium or high in terms of how much it has spread.
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I have been diagnosed with CLL or SLL.
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I agree to use barrier methods for birth control.
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I can take care of myself and perform daily activities.
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My condition requires treatment for CLL or SLL as per international guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients that have a decrease in tumor burden from levels of disease that meet "Medium/High-tumor burden" criteria to meet "Low tumor burden" criteria for disease burden following 1 or 2 cycles of HDMP + Rituximab.
Secondary outcome measures
Adverse events by CTCAE4 definitions
Overall Response rate, Partial Response rate, and Complete response rate per iwCLL criteria after 9 months of venetoclax and at completion of treatment
Percentage of patients that have a decrease in tumor burden from levels of disease that meet "Medium/High-tumor burden" c criteria to meet "Low tumor burden" criteria for disease burden following 1 cycle of HDMP + Rituximab.
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment1 Intervention
HDMP + rituximab as a means of debulking prior to initiating venetoclax.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,615 Total Patients Enrolled
Choi Michael, MDPrincipal InvestigatorUniversity of California, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of my previous treatments.I have not taken certain medications recently.I agree not to become pregnant during the study.I am 18 years old or older.I currently have an active infection.My cancer is classified as medium or high in terms of how much it has spread.I have had another type of cancer that might interfere with this study.I am not pregnant or breastfeeding.My liver is working well.I do not have any uncontrolled health conditions.I am HIV positive.My kidneys are working well.I have been diagnosed with CLL or SLL.I have been treated for CLL/SLL with at least one prior therapy.I agree to use barrier methods for birth control.My diabetes is not well-controlled.I can take care of myself and perform daily activities.I have not had certain treatments for chronic lymphocytic leukemia.I have not had major surgery recently.I am eligible regardless of my gender, race, or ethnicity.My condition requires treatment for CLL or SLL as per international guidelines.I haven't had a heart attack or significant heart disease in the last 6 months.My blood counts are within a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in the clinical trial thus far?
"Affirmative. The clinical trial registry on clinicaltrials.gov states that this specific research, which was first posted in early September 2021, is currently recruiting subjects. Only 20 people will be admitted from a single location."
Answered by AI
How has the combination of HDMP and rituximab been utilized to reduce tumor size before beginning venetoclax therapy?
"High-dose methotrexate and rituximab, when used in combination to debulk prior to administering venetoclax, is a typical treatment for diffuse large b-cell lymphoma. Additionally, it can be applied beneficially against polyangiums, pemphigus vulgaris and other B-cell lymphomas."
Answered by AI
What potential adverse effects could arise from using HDMP + rituximab for debulking prior to beginning venetoclax therapy?
"Taking into account the limited data available on the safety and efficacy of HDMP + rituximab as a method for pre-venetoclax tumor debulking, our team estimated its risk level to be 1."
Answered by AI
Does this research currently have any openings for participants?
"This study, initially posted on September 2nd 2021, is currently in the recruitment phase - according to clinicaltrials.gov's records that were last updated March 21st 2022."
Answered by AI
Has the combination of HDMP and rituximab previously been investigated as a prelude to starting venetoclax?
"Presently, 598 clinical trials are running that examine HDMP + rituximab as a means of reducing the size of tumours prior to commencing venetoclax. Of these studies, 116 are in Phase 3 and based out of Toronto, Ontario with 20 760 locations worldwide offering this treatment option."
Answered by AI
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