NCT03585725

A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma

Detailed description

This clinical trial is for men and women ages 18 and older with follicular lymphoma with detectable BCL2-t or mantle cell lymphoma with presence of cyclin D1 overexpression (can be newly diagnosed or relapsed). The objective of this study is to assess the possibility of treating follicular lymphoma and mantle cell lymphoma patients with ribavirin and using cell free DNA (cfDNA) for BCL2-t and cyclin D1 extracted from peripheral blood to measure treatment effect. Clinical trials of ribavirin have been conducted in relapsed and refractory acute myeloid leukemia (AML). Ribavirin, an antiviral agent with established doses, has resulted in the regression of the tumor. * Ribavirin 1000 mg will be administered orally twice daily continuously for 28-day cycles. * Patients will be followed for up to 7 months. * Will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Conditions

• Follicular Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ribavirin	Ribavirin is FDA-approved oral medication for antiviral indications. Ribavirin will be obtained commercially for this trial. Treatment will be administered on an outpatient basis. Ribavirin should be administered with food.

Timeline

• Start date: 2018-09-26
• Primary completion: 2020-07-22
• Completion: 2020-07-22
• First posted: 2018-07-13
• Last updated: 2021-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study