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

• Status: Terminated
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Memorial Sloan Kettering Cancer Center
• Treatments: Ribavirin

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)