Clinical trial NCT03585725: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Follicular Lymphoma
Mantle Cell Lymphoma
Keywords: Ribavirin
Follicular Lymphoma
Mantle Cell Lymphoma
Lymphoma
Non-Hodgkin lymphoma
Indolent Lymphoma
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2018-07-13
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
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
timeFrame: 18 months
Secondary outcomes:
measure: Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0
timeFrame: 18 months
measure: Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT
timeFrame: 18 months
measure: Average change in BCL2-t or Cyclin D1 cfDNA levels
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sarah Rutherford, MD
role: PRINCIPAL_INVESTIGATOR
References: