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Alkylating agents
Venetoclax for Chronic Lymphocytic Leukemia (MURANO 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to last fuv (up to approximately 3 years)
Awards & highlights
MURANO Trial Summary
This trial is testing whether a new combination of drugs, venetoclax + rituximab, is better than the current standard of care, bendamustine + rituximab, for people with relapsed or refractory CLL.
Eligible Conditions
- Chronic Lymphocytic Leukemia
MURANO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to last fuv (up to approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to last fuv (up to approximately 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 Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death
Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines
Secondary outcome measures
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores
+23 moreOther outcome measures
Change From Baseline in Lymphocyte Subset Counts at Specified Time Points
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
White blood cell count decreased
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Electrocardiogram QT prolonged
11%
Blood creatinine increased
11%
Dermatitis
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
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
MURANO Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Venetoclax + Rituximab Re-TreatmentExperimental Treatment2 Interventions
Participants entering the Re-Treatment Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Re-Treatment Day 1 of the Substudy.
Group II: Venetoclax + RituximabExperimental Treatment2 Interventions
Participants will be initially placed on a venetoclax 5 weeks ramp-up period, and will receive an initial dose of 20 milligrams (mg) via tablet orally once daily (QD). Then the dose will be incremented weekly up to a maximum dose of 400 mg. Participants will then continue receiving venetoclax 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards, as directed by the investigator, in combination with rituximab 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of Cycles 2-6.
Group III: Bendamustine + Rituximab Crossover SubstudyExperimental Treatment2 Interventions
Participants entering the Crossover Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Crossover Day 1 of the Substudy.
Group IV: Bendamustine + RituximabActive Control2 Interventions
Participants will receive bendamustine 70 milligrams per meter square (mg/m^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m^2 on Day 1 of Cycles 2-6.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,676 Total Patients Enrolled
AbbVieIndustry Sponsor
952 Previous Clinical Trials
499,381 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,056 Total Patients Enrolled
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