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Immunomodulator

Venetoclax + Lenalidomide + Rituximab for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Ubaldo R Martinez-Outschoorn, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the lenalidomide REMS program

Histologically confirmed indolent B-cell non-Hodgkin's lymphoma (NHL) of any of the following subtypes recognized by the World Health Organization (WHO) classification: Follicular lymphoma and marginal zone lymphoma. Patients with indolent non-Hodgkin's Lymphoma (iNHL) should have received at least 1 previous prior therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from study registration to death from any cause, assessed at 2 years

Awards & highlights

Study Summary

This trial is testing the combination of venetoclax, lenalidomide, and rituximab hyaluronidase to treat patients with relapsed or refractory low-grade lymphoma. The goal is to find the maximum tolerated dose of venetoclax and to learn about the side effects of this combination.

Who is the study for?

This trial is for adults with certain slow-growing lymphomas, like follicular and marginal zone lymphoma, that have either returned after treatment or haven't responded to previous therapy. Participants must have had at least one prior systemic therapy, be able to swallow pills whole, take daily aspirin or equivalent for blood clot prevention, and meet specific health criteria.Check my eligibility

What is being tested?

The study tests a combination of three drugs: Venetoclax (which blocks proteins helping cancer cells survive), Lenalidomide (an immunotherapy that may alter the immune system to hinder tumor growth), and Rituximab/Hyaluronidase (antibodies aiming to boost the immune attack on cancer). The goal is to find safe doses for patients with relapsed/refractory low-grade lymphoma.See study design

What are the potential side effects?

Potential side effects include risks associated with Venetoclax such as nausea, diarrhea, neutropenia (low white blood cell count); Lenalidomide's possible impacts like rash or fatigue; and Rituximab-related infusion reactions. Each drug can also affect how your body fights infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow the pregnancy testing schedule as required.

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I have a specific type of slow-growing lymphoma and have had at least one treatment.

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I have had at least one treatment that affects my whole body.

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I can swallow pills without any issues.

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I can take aspirin daily or use an alternative if I'm allergic.

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I can take care of myself and am up and about more than half of my waking hours.

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I am registered and agree to follow the lenalidomide REMS program requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from study registration to documented disease progression or death from any cause, assessed at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from study registration to documented disease progression or death from any cause, assessed at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study registration to documented disease progression or death from any cause, assessed at 2 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

Rate of dose-limiting toxicities

Secondary outcome measures

Overall response rate

Overall survival (OS)

Progression-free survival (PFS)

Other outcome measures

Immune profile

Level of expression and expression ratio between anti-apoptotic and pro-apoptotic BCL-2 family proteins measured by flow cytometry and messenger ribonucleic acid (mRNA)

Metabolic landscape

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (venetoclax, lenalidomide, rituximab, hyaluronidase)Experimental Treatment4 Interventions

Patient receive venetoclax PO QD on days 1-28. Beginning cycle 2, patients receive lenalidomide PO QD on days 1-21. Patients also receive rituximab IV on days 1, 8, 15, and 22 of cycle 2 and rituximab hyaluronidase (if no significant infusion reaction to rituximab) SC on day 1 of cycles 4, 6, 8, 10, and 12. Patients may receive rituximab IV (instead of rituximab hyaluronidase) on days 1, 8, 15, and 22 of cycles 4, 6, 8, 10, and 12 if the patient requires rituximab IV in the opinion of the treating physician. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Lenalidomide

2005

Completed Phase 3

~1480

Venetoclax

2019

Completed Phase 3

~1990

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

444 Previous Clinical Trials

145,594 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,123 Total Patients Enrolled

Ubaldo R Martinez-Outschoorn, MDPrincipal InvestigatorThomas Jefferson University

Frequently Asked Questions

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

Is this experiment actively inviting participation from volunteers?

"Indeed, the trial is currently admitting participants. According to clinicaltrials.gov, it was first posted on October 16th 2020 and edited most recently on April 7th 2022; 30 individuals are needed at a single site for participation."

Answered by AI

What indications is Venetoclax commonly proscribed for?

"Venetoclax is a popular medication for treating diffuse large b-cell lymphoma (dlbcl). Additionally, it can be used to address inflammatory breast cancer (ibc) and other B-Cell Lymphomas that have not responded to prior systemic chemotherapy regimens."

Answered by AI

What is the total sample size for this medical experiment?

"Affirmative. The information published on clinicaltrials.gov demonstrates that the trial, which was initially posted in October 16th 2020 is currently recruiting subjects. 30 individuals need to be enrolled at one medical facility."

Answered by AI

To what extent does Venetoclax pose a risk to patients?

"The team at Power assigned Venetoclax a score of 1 due to its Phase 1 designation, indicating that there is limited evidence supporting the drug's safety and efficacy."

Answered by AI

Are there any other trials that have utilized Venetoclax for therapeutic benefit?

"At present, there are 825 Venetoclax studies in progress with 170 of them reaching Phase 3. Toronto is the location for many of these trials while a total of 32578 sites provide access to clinical testing involving Venetoclax."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment

2020. "An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04447716.