A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03585725|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma Mantle Cell Lymphoma||Drug: Ribavirin||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.
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.
- 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 [ Time Frame: 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.
- Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585725
|Contact: Amelyn Rodriguez, RNemail@example.com|
|Contact: Rita Vaccaro, RNfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Amelyn Rodriguez, RN 212-746-1362 email@example.com|
|Contact: Rita Vaccaro, RN 212-746-0702 firstname.lastname@example.org|
|Principal Investigator: Sarah Rutherford, MD|
|Principal Investigator:||Sarah Rutherford, MD||Weill Cornell Medicine|