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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT03585725

Collaborator

Memorial Sloan Kettering Cancer Center (Other)

Enrollment

Location

Arm

21.8

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma Mantle Cell Lymphoma	Drug: Ribavirin	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 26, 2018

Actual Primary Completion Date :

Jul 22, 2020

Actual Study Completion Date :

Jul 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ribavirin Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.	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. Other Names: Virazole Rebetol Copegus

Arm

Intervention/Treatment

Experimental: Ribavirin

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

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.

Other Names:

Virazole

Rebetol

Copegus

Outcome Measures

Primary Outcome Measures

Number of participants who receive treatment for at least 3 months, have peripheral blood samples collected at baseline and monthly while on treatment, and have levels of BCL-t or cyclin D1, respectively, obtained from their peripheral blood samples [18 months]
Feasibility will be measured by the number of subjects who receive ribavirin for at least 3 months, have peripheral blood samples collected at baseline and monthly while on treatment, and have levels of BCL-t and cyclin D1, respectively, obtained from their peripheral blood samples. The intervention will be deemed feasible if all three criteria are met in 10 out of 15 subjects.

Secondary Outcome Measures

Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0 [18 months]
Tolerability of ribavirin in FL and MCL will be assessed by the number of Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0.
Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT [18 months]
Response rate will be assessed by the number of participants who achieve a response to ribavirin treatment based on PET/CT or CT at baseline and within 4 weeks after completion of treatment. International working group criteria will be used for response assessment based on imaging done at baseline and 2-4 weeks after completion of therapy. The total number of participants who achieve a response will be assessed after the last patient has their response assessed after completion of therapy.
Average change in BCL2-t or Cyclin D1 cfDNA levels [18 months]
Correlatives will be assessed by the change in BCL2-t or Cyclin D1 cfDNA levels. This will be correlated with response rates based on imaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

No individual masses larger than 6 cm in diameter
No more than three masses larger than 3 cm in diameter
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:

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)