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Monoclonal Antibodies
Venetoclax + Rituximab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have relapsed/refractory disease with an indication for treatment
Patient must have relapsed/refractory disease with an indication for treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to death (up to approximately 5 years)
Awards & highlights
Study Summary
This trial is studying how well venetoclax works in combination with rituximab/hyaluronidase human in treating patients with relapsed or refractory chronic lymphocytic leukemia.
Who is the study for?
This trial is for adults with relapsed or refractory chronic lymphocytic leukemia (CLL). Participants must have adequate organ function, an ECOG score ≤ 2 indicating they can perform daily activities with some limitations, and agree to contraception if applicable. Exclusions include other active cancers, significant uncontrolled diseases, certain infections like hepatitis B/C or HIV not under control, recent major surgery, pregnancy, and known allergies to study drugs.Check my eligibility
What is being tested?
The trial tests the effectiveness and safety of combining venetoclax with Rituximab/hyaluronidase human in treating CLL that has returned after treatment or did not respond to previous treatments. It's a Phase II study where all participants receive the same combination therapy without being compared to another group.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site from Rituximab/hyaluronidase human and gastrointestinal symptoms, low blood cell counts leading to increased infection risk or bleeding problems from Venetoclax. Liver function abnormalities could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition has worsened or not improved after treatment.
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My condition has worsened or not improved after treatment.
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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.
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I have been diagnosed with CLL according to the 2008 guidelines.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to death (up to approximately 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to death (up to approximately 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Disease Response
Duration of Responses (DOR)
Overall Survival (OS)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Venetoclax + RituximabExperimental Treatment3 Interventions
Participants will be initially placed in a venetoclax 5 weeks ramp-up period, and will be administered an initial 20 mg oral tablet dose once daily (QD), incrementing weekly up to a maximum dose of 400 mg. Participants will then continue taking venetoclax 400 mg QD from Week 5 onwards, as directed by the investigator in combination with rituximab 375 mg/m^2 IV on Day 1 of Cycle 1 followed by 13.4 mL of rituximab SC 1,600 mg/26,800 Units vial (1,600 mg rituximab and 26,800 Units hyaluronidase human) on Day 1 of Cycle 2-6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthOTHER
131 Previous Clinical Trials
28,219 Total Patients Enrolled
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,477 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition has worsened or not improved after treatment.I have HIV but it's under control with my current treatment.I am taking warfarin but am open to switching to another blood thinner if needed.My condition has worsened or not improved after treatment.You have a known allergy or sensitivity to any of the study medications.I had skin cancer or early-stage melanoma or cervical cancer treated to cure, or any cancer treated with surgery only, and have been in remission for 2+ years.I do not have severe health issues that could interfere with the treatment or increase my risk.I am on steroids for cancer treatment.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I have a significant history of liver problems.I have been tested for hepatitis C; my PCR test is negative.I am not taking strong or moderate CYP3A inhibitors.My HIV infection is not under control.My blood counts are within normal ranges, not affected by my condition or spleen issues.My kidney function is normal.My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.I had or have hidden hepatitis B but no active virus, and I agree to monthly tests.I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.I am not taking any strong or moderate drugs that speed up drug breakdown.I had a stem cell transplant from a donor within the last year.I am not able to have children or I have a recent negative pregnancy test.I have been diagnosed with CLL according to the 2008 guidelines.I haven't had major surgery in the last 6 weeks, except for diagnostic purposes.I have had another type of cancer that might interfere with this study.You are allergic to both xanthine oxidase inhibitors and rasburicase medications.I haven't taken certain medications within a week before starting venetoclax.My liver is working well.I can take care of myself and am up and about more than half of my waking hours.I cannot take medications by mouth due to a digestive condition.I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax + Rituximab
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 are currently partaking in this trial?
"Unfortunately, this clinical trial is no longer recruiting patients. Posted on April 26th 2018 and last updated March 14th 2022, it has ceased its search for candidates. If you are interested in a different study, 1522 trials focusing on leukemias such as lymphocytic chronic B-cell are actively seeking participants; additionally there are 628 Venetoclax studies looking for volunteers."
Answered by AI
Are there vacancies available for prospective participants in this experiment?
"Clinicaltrials.gov confirms that this medical trial, first launched on April 26th 2018 and recently modified on March 14th 2022, is not currently recruiting participants. However there are presently 2,150 other studies actively enlisting patients into their programs."
Answered by AI
Which maladies can Venetoclax be utilized to mitigate?
"Venetoclax is a popular choice for treating inflammatory breast cancer and has seen success in managing b-cell lymphomas, polyangium, and drug extravasation."
Answered by AI
Has Venetoclax been tested previously in any other clinical research?
"Currently, 628 clinical trials for Venetoclax are underway. Out of those experiments, 128 have reached Phase 3 status. Although the majority of these studies occur in Toronto, Ontario, there are 23772 other locations that are participating as well."
Answered by AI
Has the Food and Drug Administration given clearance for Venetoclax?
"Due to its lack of efficacy data, venetoclax was given a score of 2 on our safety scale. However, this Phase 2 trial does provide some insight into the drug's potential for being safe."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
Georgetown University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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