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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

2015

Completed Phase 3

~3250

Lenalidomide

2005

Completed Phase 3

~1480

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,667 Total Patients Enrolled

Beth ChristianLead Sponsor

2 Previous Clinical Trials

61 Total Patients Enrolled

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,949 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT02992522 — Phase 1

Marginal Zone Lymphoma Research Study Groups: Treatment (lenalidomide, venetoclax, obinutuzumab)

Marginal Zone Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT02992522 — Phase 1

Lenalidomide (Immunomodulatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02992522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When was the last time Obinutuzumab was cleared by the FDA?

"This drug is still in the early stages of testing, so there is limited data supporting its safety and efficacy. Our team at Power estimates that it has a safety rating of 1 out of 3."

Answered by AI

What are the most popular applications for Obinutuzumab?

"Obinutuzumab can be used as a treatment for patients that have undergone at least two rounds of systemic chemotherapy, those with amyloidosis, and those with muscular dystrophy."

Answered by AI

Is it possible to join this experiment currently?

"This clinical trial, as seen on clinicaltrials.gov, is not presently looking for patients to enroll. The study was initially posted on February 21st 2017 and was most recently updated on April 18th 2022. Even though this particular trial isn't recruiting right now, there are 3333 other studies that are actively looking for participants."

Answered by AI

How many test subjects are part of this experiment?

"At the moment, this particular clinical trial is not seeking any more participants. It was initially posted on February 21st, 2017 and last edited on April 18th, 2022. However, there are 2778 other trials for grade 3a follicular lymphoma that are currently looking for patients as well as 555 studies involving Obinutuzumab."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Beth Christian 2017. "Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02992522.

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