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

NCT03585725

Description:

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

Related Conditions:
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
RibavirinVirazole, Rebetol, CopegusRibavirin

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

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

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

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