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

Weill Cornell Medicine (WCM)

Status and phase

Terminated

Early Phase 1

Conditions

Mantle Cell Lymphoma

Follicular Lymphoma

Treatments

Drug: Ribavirin

Study type

Interventional

Funder types

Other

Identifiers

NCT03585725

1709018594

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)