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Immunomodulatory agent

Obinutuzumab + Venetoclax + Lenalidomide for B-Cell Non-Hodgkin's Lymphoma

Phase 1

Waitlist Available

Led By Beth Christian, MD

Research Sponsored by Beth Christian

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of a combination of venetoclax, lenalidomide, and obinutuzumab in treating B-cell NHL that has returned or not responded to treatment.

Who is the study for?

This trial is for adults with B-cell non-Hodgkin lymphoma that has come back or didn't respond to treatment. They must be in good physical condition, have not used certain drugs like venetoclax before, and have proper kidney function. Women who can get pregnant must follow strict pregnancy testing rules. People with severe allergies, recent major surgery, active infections, or other serious health issues cannot join.

What is being tested?

The study tests the combination of three drugs: Obinutuzumab (a monoclonal antibody), Venetoclax (blocks enzymes for cell growth), and Lenalidomide (chemotherapy). It aims to find the safest doses and see how well they work together against different types of B-cell non-Hodgkin lymphoma.

What are the potential side effects?

Possible side effects include reactions to the infusion of obinutuzumab, digestive problems from lenalidomide and venetoclax affecting absorption or metabolism. There's also a risk of liver issues due to drug interactions and potential complications from underlying conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD defined as the highest level at which no more than 6 patients experience a DLT assessed by National Cancer Institute Common Terminology Criteria of Adverse Events version 4

Secondary study objectives

Objective response rate (ORR) defined as the proportion of patients achieving a complete or partial, response according to the Lugano Lymphoma Response Criteria

Progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, venetoclax, obinutuzumab)Experimental Treatment3 Interventions

Patients receive lenalidomide PO on days 1-21 and venetoclax PO on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of course 1, and day 1 of courses 2-6. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obinutuzumab

2014

Completed Phase 3

~3470

Lenalidomide

2005

Completed Phase 3

~2240