Description:
This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma
and Mantle Cell Lymphoma
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
1709018594
- NCT ID:
NCT03585725
Conditions
- Follicular Lymphoma
- Mantle Cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Ribavirin | Virazole, Rebetol, Copegus | Ribavirin |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Ribavirin | Experimental | Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles. | |
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:
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)
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0 |
| Time Frame: | 18 months |
| Safety Issue: | |
| 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. |
| Measure: | Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT |
| Time Frame: | 18 months |
| Safety Issue: | |
| 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. |
| Measure: | Average change in BCL2-t or Cyclin D1 cfDNA levels |
| Time Frame: | 18 months |
| Safety Issue: | |
| 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. |
Details
| Phase: | Early Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Weill Medical College of Cornell University |
Trial Keywords
- Ribavirin
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Lymphoma
- Non-Hodgkin lymphoma
- Indolent Lymphoma
Last Updated
September 28, 2020
