Triple Therapy for Lymphoma
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of alisertib and bortezomib when given together with rituximab in treating patients with mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Alisertib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving alisertib and bortezomib together with rituximab may be a better treatment for relapsed or refractory mantle cell lymphoma or B-cell low grade non-Hodgkin lymphoma.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. You must stop using proton pump inhibitors at least 4 days before the first dose, and you cannot take them during the study. Other medications like H2 receptor antagonists, antacids, pancreatic enzymes, and certain antiepileptic drugs are also not allowed during the trial.
What data supports the effectiveness of the drug combination including Alisertib, MLN8237, Bortezomib, Velcade, Rituximab, Rituxan, Riabni, Ruxience, and Truxima for treating lymphoma?
Research shows that combining rituximab with other drugs like bortezomib can be effective in treating certain types of lymphoma, such as follicular lymphoma. Rituximab, a key component of this combination, has been shown to improve survival rates when added to chemotherapy for various lymphomas.12345
Is the triple therapy for lymphoma safe for humans?
What makes the triple therapy for lymphoma unique?
The triple therapy for lymphoma combines Alisertib, Bortezomib, and Rituximab, which is unique because it integrates targeted therapies like Rituximab, a monoclonal antibody that targets CD20 on B-cells, with other agents like Bortezomib, a proteasome inhibitor, potentially enhancing treatment effectiveness by attacking the cancer cells through different mechanisms.13111213
Research Team
Catherine S Diefenbach
Principal Investigator
Montefiore Medical Center - Moses Campus
Eligibility Criteria
This trial is for adults with relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma. Participants must have adequate organ function, no high-grade cancer transformation, and agree to use contraception. They should not have had certain treatments recently and must be able to take oral medication.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive alisertib orally twice daily on days 1-7, bortezomib subcutaneously on days 1, 8, and 15, and rituximab intravenously on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Extended Treatment
After 8 courses, treatment with rituximab repeats once every 3 courses (12 weeks) in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Alisertib
- Bortezomib
- Rituximab
Alisertib is already approved in United States, European Union for the following indications:
- Acute myeloid leukemia (AML)
- None approved; under investigation for various cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor