Selinexor + Chemotherapy for Non-Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with RCHOP and also study the efficacy of this combination for therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better in treating patients with B cell non-Hodgkin lymphoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have had prior chemotherapy or immunotherapy, you must wait at least 2 weeks before starting the trial treatment.
What data supports the effectiveness of the drug Selinexor for treating non-Hodgkin's lymphoma?
Research shows that Selinexor, a drug that blocks a protein involved in cancer cell growth, has shown promising results in treating non-Hodgkin's lymphoma. In a study, 31% of patients with this type of cancer had positive responses, including some complete and partial recoveries, indicating its potential effectiveness.12345
Is the combination of Selinexor and chemotherapy safe for treating Non-Hodgkin's Lymphoma?
Selinexor has been studied in patients with Non-Hodgkin's Lymphoma and other cancers, showing some common side effects like low blood cell counts, fatigue, and low sodium levels. However, it is generally considered safe at the recommended dose, with serious organ-related side effects being rare.12467
What makes the drug Selinexor unique for treating Non-Hodgkin's Lymphoma?
Research Team
Dipenkumar Modi, M.D.
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Eligibility Criteria
This trial is for adults with advanced B-cell non-Hodgkin lymphoma, including newly diagnosed and first relapse patients. It's suitable for those who haven't had anthracycline chemotherapy before or have only used non-anthracycline therapy once. Participants must be in good physical condition (ECOG <=1), not pregnant, willing to use contraception, and have a life expectancy over 6 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1B Treatment
Dose escalation of Selinexor in combination with RCHOP chemotherapy to establish the recommended phase 2 dose
Phase 2 Treatment
Treatment with recommended phase 2 dose of Selinexor plus RCHOP for newly diagnosed DLBCL patients
Maintenance
Patients achieving partial response or better receive maintenance Selinexor for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Selinexor
Selinexor is already approved in United States, Canada for the following indications:
- Multiple myeloma
- Diffuse large B-cell lymphoma
- Multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barbara Ann Karmanos Cancer Institute
Lead Sponsor
National Cancer Institute (NCI)
Collaborator