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Trial record 72 of 1148 for:    "Follicular lymphoma"

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
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Mantle Cell Lymphoma Drug: Ribavirin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ribavirin

Arm Intervention/treatment
Experimental: Ribavirin
Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles.
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.

Other Names:
  • Virazole
  • Rebetol
  • Copegus




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585725


Contacts
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Contact: Amelyn Rodriguez, RN 212-746-1362 amr2017@med.cornell.edu
Contact: Rita Vaccaro, RN 212-746-0702 rig9021@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Amelyn Rodriguez, RN    212-746-1362    amr2017@med.cornell.edu   
Contact: Rita Vaccaro, RN    212-746-0702    rig9021@med.cornell.edu   
Principal Investigator: Sarah Rutherford, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Sarah Rutherford, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03585725     History of Changes
Other Study ID Numbers: 1709018594
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Ribavirin
Follicular Lymphoma
Mantle Cell Lymphoma
Lymphoma
Non-Hodgkin lymphoma
Indolent Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents