Venetoclax for Lymphoma, Mantle-Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
Mayo Clinic, Rochester, MN
Lymphoma, Mantle-Cell+2 More
Venetoclax - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, Mantle-Cell

Study Summary

Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age

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Eligible Conditions

  • Lymphoma, Mantle-Cell
  • Lymphoma
  • Mantle Cell Lymphoma (MCL)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Venetoclax will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma, Mantle-Cell. Measurement will happen over the course of 8 months.

57 months
Overall Survival (OS)
Progression-Free Survival (PFS)
8 months
Complete Response (CR) rate at end of induction
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Overall Response Rate (ORR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Induction

This trial requires 33 total participants across 2 different treatment groups

This trial involves 2 different treatments. Venetoclax is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

InductionVenetoclax, bendamustine and rituximab as induction therapy for 6 cycles of 28 days.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Bendamustine
FDA approved
Rituximab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 57 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 57 months for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Platelets ˃75,000/mm³
Absolute Neutrophil Count (ANC) ≥ 1000/mm³
Patients must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL), with documented cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH.
Patients must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension.
Age ≥ 60 years.
No intention to undergo consolidation with high dose chemotherapy and autologous stem cell rescue (Autologous Stem Cell Transplant) in first remission.
ECOG performance status of 0-2.
Ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent.
Willing to provide mandatory tissue samples (if sufficient tissue available), bone marrow and blood samples for research purposes.
Hemoglobin ≥ 8 g/dL

Patient Q&A Section

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

How many people get lymphoma, mantle-cell a year in the United States?

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About 3.8 million Americans are currently diagnosed lymphoma, mantle-cell in the Unites States. In our opinion our data suggest that a substantial number of people get mantle cell lymphomas during their lifetime.

Unverified Answer

What is lymphoma, mantle-cell?

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Lymphoma, mantle-cell is a cancer of lymphocytes that originates in the lymphoid follicles, usually in the intestine, and generally manifests with extraintestinal lymphadenopathy as a disseminated form. Survival is prolonged in patients with mantle-cell lymphoma who undergo intensive chemotherapy before entering remission.

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What are common treatments for lymphoma, mantle-cell?

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Almost all treatments for lymphoma can be grouped into 5 categories. You can find more information [with power(http://www.withpower.com/clinical-trials)] for each treatment by using [Power(http://www.withpower.com/clinical-trials)]. These categories provide doctors and patients with a common vocabulary to use when discussing treatments with the treatment plan.

Unverified Answer

Can lymphoma, mantle-cell be cured?

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Lymphoma, mantle-cell, cannot be cured. In most cases, patients may be well within 3 years, and in some cases within 8 years from diagnosis. Lymphoma, mantle-cell is a very poor prognosis. Treatment of lymphoma is challenging, as all patients require intensive management of their disease by physicians trained in both internal medicine and pathology.

Unverified Answer

What are the signs of lymphoma, mantle-cell?

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A wide range of unexplained conditions, including swelling of the lymph nodes, fevers, and pain, are of unclear cause. Lymphadenopathy is the most common feature of lymphoma, and should be sought when lymphadenopathy is seen. There is little evidence to support the concept of 'atypical' lymphoid hyperplasia.

Unverified Answer

What causes lymphoma, mantle-cell?

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This is a rare type of non-Hodgkin's lymphoma, and the malignant plasma cells occur in lymphoid tissue and involve the paracortex and cortical mantle zones. Immunoglobulin class of IgG was found in the majority of cases, and a significant number of mantle-cell lymphomas had a chromosomal translocation t(11;18)(q21;q21) that is the hallmark of a subset of DLBCL, the translocation t(6;14)(p22;q32), also seen in ALCL. We suggest that mantle-cell lymphoma is a form of indolent lymphoma of the paracortex/cortical mantle zone.

Unverified Answer

Is venetoclax safe for people?

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Venetoclax administered at an initial dose of 200, 400, and 500 mg BID is well tolerated in people with good marrow function, including people with MM or WMML.

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How does venetoclax work?

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The FDA approved Venetoclax in January of 2009 for the treatment of relapsed or refractory [mantle cell lymphoma](https://www.withpower.com/clinical-trials/mantle-cell-lymphoma). Venetoclax was previously in clinical trials for relapsed/refractory Hodgkin lymphoma and relapsed/refractory non-Hodgkin's lymphoma. Patients are treated for 20 doses, and then on a day 28 withdrawal regimen. The average daily dose is 200 mg Venetoclax. [MedLine Plus] There are no published adverse event reports for venetoclax.

Unverified Answer

What are the common side effects of venetoclax?

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Although no specific side effects of venetoclax were found during clinical trials, safety data from patients enrolled in the aforementioned studies suggest that venetoclax is generally well tolerated, and the most common side effects, like nausea, vomiting, abdominal pain, diarrhea, fever, and dizziness, were mild or moderate. Further safety investigations are recommended to explore the unique side effects of venetoclax.

Unverified Answer

How quickly does lymphoma, mantle-cell spread?

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Lymphoma tends to spread slowly with time. This was likely the effect of the long latency of lymphoma. However, patients are still at risk for early spread and need to be monitored for disease-related complications from the disease.

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Have there been any new discoveries for treating lymphoma, mantle-cell?

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Although much of the research into lymphoma treatment focuses on its treatment using new monoclonal antibody therapies, the advancement of research into targeted therapies for the disease is ongoing, with the most notable candidate being cemiplimab (Nelarabine), which is showing promise in a phase II trial in mantle-cell lymphoma. Lymphoma has been a highly studied disease with the advent of immunotherapy. Immunotherapy is a term that includes all types of cancer treatment that uses the body's own immune system to destroy cancer cells. Immunotherapy is categorized according to the type of cancer it treats by type of cancer stem-cells.

Unverified Answer

Who should consider clinical trials for lymphoma, mantle-cell?

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Clinical trials for lymphoma are difficult to find, but lymphoma clinical trials are not equally distributed. Lymphoma clinical trials are best accessed through Power or the NCI website, both of which specialize in finding clinical trials for lymphoma.

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