Triple Therapy for Follicular Lymphoma
(LEVERAGE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Peter MacCallum Cancer Centre, Australia

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Patient has provided written informed consent.

I meet at least one criterion for needing treatment for my lymphoma.

- International normalized ratio >1.5 x ULN for patients not receiving therapeutic anticoagulation

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Exclusion Criteria

Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody.

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.

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Treatment Details

Interventions

Lenalidomide (Small Molecule)
Obinutuzumab (Anti-tumor antibody)
Venetoclax (Small Molecule)

Trial OverviewThe 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.

Participant Groups

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.