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

NCT ID: NCT03585725

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2020-07-22

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ribavirin

Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.

Group Type: EXPERIMENTAL

Ribavirin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Virazole; Rebetol; Copegus

Eligibility Criteria

Inclusion Criteria

• Diagnosis of histologically confirmed follicular lymphoma with detectable BCL2-t or mantle cell lymphoma with presence of cyclin D1 overexpression (can be newly diagnosed or relapsed)
• Measurable disease (At least one tumor mass > 1 cm in diameter)
• Low tumor burden:

1. No individual masses larger than 6 cm in diameter

2. No more than three masses larger than 3 cm in diameter

3. No lymphoma-related symptoms

• The treating physician does not feel that treatment with chemotherapy is indicated
• ECOG performance status of 0-2
• Adequate bone marrow and end organ function:

i. ANC≥1500/mm3, hemoglobin≥10 g/dL, platelet≥100/mm3 ii. CrCL≥50 mL/min by Cockcroff Gault calculation

Exclusion Criteria

• Indication for treatment of lymphoma including large tumor burden or symptomatic disease
• Pregnancy or men whose female partners are pregnant
• Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment)
• Significant or unstable cardiac disease
• Hemoglobinopathy (thalassemia or sickle cell disease)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Rutherford, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

1709018594

Identifier Type: -

Identifier Source: org_study_id