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Small Molecule
Triple Therapy for Follicular Lymphoma (LEVERAGE Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Peter MacCallum Cancer Centre, Australia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bi-dimensionally measurable disease, with at least one mass lesion ≥ 2 cm in longest diameter.
- Creatinine clearance ≥50ml/min(Cockcroft-Gault)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from commencement of treatment to end of study (6.75 years)
Awards & highlights
LEVERAGE Trial Summary
This trial will investigate a new combination treatment for patients with treatment-naïve follicular lymphoma. The treatment will last for 0.5 years with the possibility of maintenance treatment for up to 2 years. Patients will be followed up for 3 years after the last patient completes induction treatment.
Who is the study for?
This trial is for adults with untreated follicular lymphoma who have measurable disease, normal organ function, and an ECOG performance status ≤ 2. They must not have other active cancers or infections, no history of certain brain events within the last 6 months, and cannot be pregnant. Participants should agree to use effective contraception during the study.Check my eligibility
What is being tested?
The study tests a combination therapy using Venetoclax, Lenalidomide, and Obinutuzumab in patients with treatment-naïve follicular lymphoma. It involves an initial half-year induction phase followed by up to two years of maintenance treatment based on response to induction.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk; blood cell count changes; liver enzyme alterations; allergic reactions; digestive issues like nausea or constipation; fatigue; and possible infusion-related reactions.
LEVERAGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that is at least 2 cm large.
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My kidneys are working well.
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My lymphoma is confirmed to be a specific type and stage according to a 2014 criteria.
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I am able to care for myself and perform daily activities.
LEVERAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from commencement of treatment to end of study (6.75 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from commencement of treatment to end of study (6.75 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events (AEs) of venetoclax, lenalidomide and obinutuzumab
CR at 2.5 years from commencement of induction treatment
Complete response (CR) at the end of induction
+9 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
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
LEVERAGE Trial Design
1Treatment groups
Experimental Treatment
Group I: Obinutuzumab+venetoclax+lenalidomideExperimental Treatment3 Interventions
Patients in both dose escalation and dose expansion will receive 6 cycles of induction treatment consisting of obinutuzumab (flat dose of 1000mg) and protocol defined dose levels of venetoclax and lenalidomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
FDA approved
Venetoclax
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
Peter MacCallum Cancer Centre, AustraliaLead Sponsor
95 Previous Clinical Trials
25,446 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or unhealed wounds in the last 4 weeks.I have received treatment other than steroids for my follicular lymphoma.I do not have any severe illnesses that could affect my safety or the study's results.I don't have active hepatitis C or B but will follow preventive treatment if needed.I meet at least one criterion for needing treatment for my lymphoma.My previous cancer has been in remission for 2+ years without treatment.I have not taken certain medications within the last week.I haven't taken steroids for cancer, except possibly a short course to manage symptoms.I have had a stroke or brain bleed in the last 6 months.I do not have any active infections, except for fungal infections of the nail beds.I have not received any live-virus vaccines in the last 28 days and do not need any during the study.I have a tumor that is at least 2 cm large.My kidneys are working well.My lymphoma has progressed to a more aggressive form.I have had skin cancer or early-stage melanoma but am now cured.I am not allergic to the study drugs or similar medications.I am not taking any strong CYP3A inducer medications.My lymphoma is confirmed to be a specific type and stage according to a 2014 criteria.I am 18 years old or older.I am able to care for myself and perform daily activities.My blood and organ tests are within normal ranges.My bilirubin levels are within normal limits, except if due to specific conditions.I agree to follow strict birth control measures or abstain from sex during and after the study as required.I cannot swallow pills.I am not taking strong CYP3A inhibitors.I agree to use protection during sex throughout the study and for up to 18 months after, even if I've had a vasectomy.I need to take vitamin K antagonists due to potential interactions with warfarin.I have lymphoma in my brain or spinal cord.You have eaten grapefruit, grapefruit products, Seville oranges (including marmalade with Seville oranges), or star fruit within the past 3 days.
Research Study Groups:
This trial has the following groups:- Group 1: Obinutuzumab+venetoclax+lenalidomide
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is enrollment for this experiment still open?
"This clinical study is actively seeking volunteers, as indicated in updated reports posted on clinicaltrials.gov. It was first announced on August 19th 2019 and modified most recently on November 4th 2022."
Answered by AI
What prior experiments have been conducted utilizing Venetoclax?
"Currently, 539 clinical trials are taking place concerning Venetoclax. Of those studies, 91 have reached Phase 3 status. While Edmonton is the main hub for this research effort, data collection is occurring in 21 798 locations worldwide."
Answered by AI
How is Venetoclax typically employed to alleviate symptoms?
"Venetoclax is widely used to treat those who have undergone two rounds of systemic chemotherapy, as well as amyloidosis, muscular dystrophy, and hemopoietic stem cell transplant."
Answered by AI
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