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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03585725
• Other study ID #: 1709018594
• Status: Terminated
• Phase: Early Phase 1
• Start date: September 26, 2018
• Est. completion date: July 22, 2020

Study information

• Verified date: September 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 22, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	18 months
Secondary	Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0	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.	18 months
Secondary	Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT	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.	18 months
Secondary	Average change in BCL2-t or Cyclin D1 cfDNA levels	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.	18 months