28 Participants Needed

Venetoclax + Lenalidomide + Rituximab for Mantle Cell Lymphoma

Recruiting at 4 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that affect liver enzymes (CYP3A inhibitors or inducers) within one week before starting the trial treatment.

What data supports the effectiveness of the drug combination of Venetoclax, Lenalidomide, and Rituximab for treating Mantle Cell Lymphoma?

A study showed that adding Venetoclax to Lenalidomide and Rituximab was safe and effective for patients with untreated Mantle Cell Lymphoma, with 96% of patients responding to the treatment and 86% achieving complete response.12345

Is the combination of Venetoclax, Lenalidomide, and Rituximab safe for humans?

The combination of Venetoclax, Lenalidomide, and Rituximab has been found to be safe in patients with untreated mantle cell lymphoma, with common side effects including low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). Venetoclax, when used alone or with Rituximab, has also shown a manageable safety profile in patients with chronic lymphocytic leukemia.13467

What makes the drug combination of Venetoclax, Lenalidomide, and Rituximab unique for treating Mantle Cell Lymphoma?

This drug combination is unique because it combines Venetoclax, a BCL-2 inhibitor, with Lenalidomide and Rituximab to enhance treatment effectiveness for untreated Mantle Cell Lymphoma, achieving high response rates and minimal residual disease undetectability, which is not commonly seen with other treatments.13478

What is the purpose of this trial?

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).

Research Team

TP

Tycel Phillips, M.D.

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults over 18 with untreated Mantle Cell Lymphoma, who are in relatively good health (ECOG ≤2), not pregnant or breastfeeding, and can take oral medication. They must join the Revlimid REMS® program, agree to pregnancy testing if applicable, use contraception, and have no recent strong drug interactions or other cancers within 2 years.

Inclusion Criteria

I agree to follow the pregnancy testing schedule as required.
My tests show I have mantle cell lymphoma.
I can swallow pills.
See 6 more

Exclusion Criteria

Pregnant or breastfeeding women
My cancer has spread to my brain or spinal cord.
I have had cancer before, but it was either skin cancer treated successfully, cervical cancer that did not spread, or any cancer I've been free from for 2+ years.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive venetoclax, lenalidomide, and rituximab. Rituximab is administered on specific days across multiple cycles, lenalidomide is given in varying doses across cycles, and venetoclax is administered with a ramp-up dose in cycle 1 and a consistent dose in cycles 2-12.

12 cycles
Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including PET, CT scans, and bone marrow examinations.

Up to 4 years

Treatment Details

Interventions

  • Lenalidomide
  • Rituximab
  • Venetoclax
Trial Overview The study tests a combination of venetoclax with lenalidomide and rituximab for safety and effectiveness against MCL. Participants will receive this experimental treatment to see how well it works compared to current treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Venetoclax, Lenalidomide, RituximabExperimental Treatment3 Interventions
Rituximab 375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12 Lenalidomide 10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12. Venetoclax PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.

Lenalidomide is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Revlimid for:
  • Multiple myeloma
  • Myelodysplastic syndromes
  • Mantle cell lymphoma
  • Follicular lymphoma
  • Marginal zone lymphoma
🇺🇸
Approved in United States as Revlimid for:
  • Multiple myeloma
  • Myelodysplastic syndromes
  • Mantle cell lymphoma
  • Follicular lymphoma
  • Marginal zone lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Findings from Research

In a multicenter study of 28 patients with untreated mantle cell lymphoma (MCL), the combination of lenalidomide, rituximab, and venetoclax demonstrated a high overall response rate of 96% and a complete response rate of 86%, indicating strong efficacy for this treatment regimen.
The treatment was found to be safe, with no dose-limiting toxicities reported, although common side effects included neutropenia and thrombocytopenia, suggesting that this combination could be a promising option for patients who are ineligible for transplantation.
Adding venetoclax to lenalidomide and rituximab is safe and effective in patients with untreated mantle cell lymphoma.Phillips, TJ., Bond, D., Takiar, R., et al.[2023]
The maximum tolerated dose (MTD) of lenalidomide when combined with rituximab for treating relapsed or refractory mantle-cell lymphoma (MCL) was determined to be 20 mg, with the combination showing a manageable safety profile despite some grade 3-4 hematological toxicities.
In a phase 2 trial involving 44 patients, the combination therapy resulted in a 57% overall response rate, with 36% achieving a complete response and a median overall survival of 24.3 months, indicating its efficacy in this patient population.
Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial.Wang, M., Fayad, L., Wagner-Bartak, N., et al.[2023]
Venetoclax is an effective oral treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), showing durable responses and a manageable safety profile in clinical trials, including patients with poor prognostic factors.
In combination with rituximab, venetoclax significantly improved progression-free survival and achieved undetectable minimal residual disease compared to bendamustine plus rituximab, with benefits lasting for at least 36 months.
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia.Scott, LJ.[2020]

References

Adding venetoclax to lenalidomide and rituximab is safe and effective in patients with untreated mantle cell lymphoma. [2023]
Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. [2023]
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. [2020]
Addition of rituximab in relapsed/refractory chronic lymphocytic leukemia after progression on venetoclax monotherapy. [2022]
Lenalidomide: A Review in Previously Treated Follicular Lymphoma. [2021]
Phase 1/2 study of venetoclax, a BCL-2 inhibitor, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. [2021]
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Relationship between venetoclax exposure, rituximab coadministration, and progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia: demonstration of synergy. [2018]
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