NCT03585725

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 26, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2020

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

May 25, 2018

Last Update Submit

September 20, 2021

Conditions

Follicular LymphomaMantle Cell Lymphoma

Keywords

RibavirinFollicular LymphomaMantle Cell LymphomaLymphomaNon-Hodgkin lymphomaIndolent Lymphoma

Outcome Measures

Primary Outcomes (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

    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.

    18 months

Secondary Outcomes (3)

  • Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0

    18 months

  • Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT

    18 months

  • Average change in BCL2-t or Cyclin D1 cfDNA levels

    18 months

Study Arms (1)

Ribavirin

EXPERIMENTAL

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

Drug: Ribavirin

Interventions

RibavirinDRUG

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.

Also known as: Virazole, Rebetol, Copegus
Ribavirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Mantle-CellLymphomaLymphoma, Non-Hodgkin

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Sarah Rutherford, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

July 13, 2018

Study Start

September 26, 2018

Primary Completion

July 22, 2020

Study Completion

July 22, 2020

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)