Follicular LymphomaEarly Phase 1NCT03585725
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
A Early Phase 1 study testing Ribavirin in people with Follicular Lymphoma and Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2018to 22 Jul 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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:
- ANC≥1500/mm3, hemoglobin≥10 g/dL, platelet≥100/mm3 ii. CrCL≥50 mL/min by Cockcroff Gault calculation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This is a A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
Read the 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.
- Conditions
- Follicular Lymphoma, Mantle Cell Lymphoma
- Being tested
- Ribavirin
- Keywords
- Ribavirin, Follicular Lymphoma, Mantle Cell Lymphoma, Lymphoma, Non-Hodgkin lymphoma, Indolent Lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Also called Virazole, Rebetol, Copegus
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.
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin | Experimental | Ribavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles. Receives: Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0
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.
Measured: 18 months
Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT
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.
Measured: 18 months
Average change in BCL2-t or Cyclin D1 cfDNA levels
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start26 Sep 2018
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Sarah Rutherford, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585725
- Sponsor's protocol ID
- 1709018594
- Status last verified
- Sep 2021
- First submitted
- 25 May 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03585725
- Acronym / sponsor ID
- 1709018594
- Conditions
- Follicular Lymphoma, Mantle Cell Lymphoma
- Keywords
- Ribavirin, Follicular Lymphoma, Mantle Cell Lymphoma, Lymphoma, Non-Hodgkin lymphoma, Indolent Lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribavirin | Experimental | Drug: RibavirinRibavirin 1000 mg will be administered orally twice daily continuously in 28 day cycles for up to 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- The treating physician does not feel that treatment with chemotherapy is indicated
- ECOG performance status of 0-2
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinAlso: Virazole, Rebetol, CopegusRibavirin 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. | Drug | Ribavirin |
Primary outcome
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.
3 secondary outcomes
Number of participants with treatment-related Serious Adverse Events as assessed by the CTCAE v4.0
Time frame: 18 months
Number of participants who achieve a response to ribavirin treatment based on PET/CT or CT
Time frame: 18 months
Average change in BCL2-t or Cyclin D1 cfDNA levels
Time frame: 18 months
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Rutherford, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ribavirin in people with Follicular Lymphoma and Mantle Cell Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.