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

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.

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)