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Nemtabrutinib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 108 months
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a new combo drug therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Who is the study for?
This trial is for people with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who have tried at least one therapy before. They must be able to take oral meds, not be pregnant or breastfeeding, and use effective contraception if necessary. They should have a life expectancy of over 3 months and good organ function.Check my eligibility
What is being tested?
The study tests the combination of Nemtabrutinib plus Venetoclax against Venetoclax with Rituximab in treating CLL/SLL. It aims to see if the new combo improves how long patients live without their disease getting worse compared to the existing treatment option.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion, fatigue, digestive issues that might affect drug absorption, blood disorders including severe bleeding problems, increased risk of infections due to hepatitis B or C virus reactivation, and potential interactions with other drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 108 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 108 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of participants discontinuing study treatment due to AEs
Part 1: Number of participants experiencing adverse events (AEs)
Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)
+1 moreSecondary outcome measures
Part 2: Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
Part 2: Number of participants discontinuing study treatment due to AEs
Part 2: Number of participants experiencing AEs
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nemtabrutinib + VenetoclaxExperimental Treatment2 Interventions
Participants will receive nemtrabrutinib oral tablets at specified doses daily starting at Cycle 1 Day 1 (C1D1) and venetoclax oral tablets at doses of 20 mg up to 400 mg daily starting at Cycle 2 Day 1 (C2D1) up to 2 years post C2D1 or until progressive disease (PD) or discontinuation. A cycle = 4 weeks.
Group II: Venetoclax + RituximabActive Control2 Interventions
Participants will receive venetoclax oral tablets at doses from 20 mg up to 400 mg daily starting at C1D1 on 4-week cycles up to 2 years and rituximab or biosimilar at 375 mg/m^2 up to 500 mg/m2 intravenous infusion once per 28-day cycle starting at C2D1, for 6 total cycles. Treatment will continue until progressive disease (PD) or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,426 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,684 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with CLL/SLL and need treatment.My organ function is good, tested within the last week.I am still recovering from major surgery or have complications.I am HBsAg positive but have been on HBV therapy for 4 weeks with undetectable HBV DNA.I have my genetic test results for specific mutations and deletions ready.I am not pregnant, breastfeeding, and if able to bear children, I use effective birth control.I have HIV but meet all the trial's eligibility criteria.I am HIV-positive with a history of specific conditions or infections in the last year.I have an active hepatitis B or C infection.I have a digestive issue that could affect how my body absorbs medication.I have another cancer that is growing or was treated in the last 3 years.My CLL/SLL has transformed or spread to my brain.I am not allergic to nemtabrutinib, venetoclax, rituximab, or their ingredients.I have not had a live vaccine in the last 30 days.I've had cancer treatment within the last 4 weeks or 5 half-lives of the drug.I have a severe bleeding disorder like hemophilia.I am currently on medication that affects how drugs are processed in my body.I can care for myself and am up more than 50% of my waking hours.I can swallow and keep down pills.I have been treated with BCL2 or BTK inhibitors like venetoclax.My condition did not improve after at least one treatment.I am currently on IV antibiotics for an infection.I had hepatitis C but my current tests show no detectable virus.I agree to follow specific contraception guidelines if I can produce sperm.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax + Rituximab
- Group 2: Nemtabrutinib + Venetoclax
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the combination of Nemtabrutinib and Venetoclax been given government endorsement?
"Our team has calculated that the combination of Nemtabrutinib and Venetoclax is a 3 on the safety scale, due to clinical data confirming its efficacy and multiple rounds verifying it is safe for human use."
Answered by AI
Are there any openings remaining for participants in this investigation?
"Affirmative. Clinicaltrials.gov shows that enrollment is open for this medical study, initially posted on August 8th 2023 and last amended on the 30th of August 2023. 720 patients need to be recruited from 3 clinical centres."
Answered by AI
How many individuals are enrolled in this clinical experiment?
"Yes, the data accessible through clinicaltrials.gov states that this medical trial is actively enrolling participants. It was first posted on August 8th 2023 and has been updated most recently on August 30th 2023; the study necessitates 720 patients to be recruited from 3 sites."
Answered by AI
What is the primary objective of this experiment?
"This clinical trial will run for a duration of up to 28 months and the main objective is to measure how many participants discontinue treatment due to adverse events. Secondary objectives include measuring patient response, undetectable minimal residual disease rate in bone marrow as evaluated by an external laboratory, and overall survival from randomization until death."
Answered by AI
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