Back to resultsA Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
Primary Purpose
Follicular Lymphoma, Mantle Cell Lymphoma
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Ribavirin, Follicular Lymphoma, Mantle Cell Lymphoma, Lymphoma, Non-Hodgkin lymphoma, Indolent Lymphoma
Eligibility Criteria
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:
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)
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ribavirin
Arm Description
Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.
Outcomes
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
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
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
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
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.
Full Information
NCT ID
NCT03585725
First Posted
May 25, 2018
Last Updated
September 20, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT03585725
Brief Title
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
Official Title
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
July 22, 2020 (Actual)
Study Completion Date
July 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma, Mantle Cell Lymphoma
Keywords
Ribavirin, Follicular Lymphoma, Mantle Cell Lymphoma, Lymphoma, Non-Hodgkin lymphoma, Indolent Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ribavirin
Arm Type
Experimental
Arm Description
Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Virazole, Rebetol, Copegus
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0
Description
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.
Time Frame
18 months
Title
Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT
Description
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.
Time Frame
18 months
Title
Average change in BCL2-t or Cyclin D1 cfDNA levels
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Rutherford, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
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