Monitoring the safety of Revlimid® in patients with relapsed or refractory lymphoma
Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)
Celgene · NCT04618081
This study is testing the safety of Revlimid® in people with relapsed or refractory lymphoma who have just started treatment with it and rituximab, to see how it affects their bone marrow and any tumor flare-ups.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celgene (industry) |
| Drugs / interventions | rituximab |
| Locations | 1 site (Japan) |
| Trial ID | NCT04618081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety of Revlimid® Capsules at doses of 2.5 mg or 5 mg in patients who have received R2 combination therapy with the drug and rituximab for the first time. It focuses on collecting data regarding the occurrence of bone marrow depression, specifically neutropenia, and any tumor flare events. The planned registration period for this surveillance is 1.5 years, with a total surveillance duration of 3 years from the start of the survey. The study will gather real-world data to better understand the safety profile of this treatment in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Not a fit: Patients who are not diagnosed with follicular lymphoma or marginal zone lymphoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of Revlimid® for patients with specific types of lymphoma, potentially leading to improved treatment protocols.
How similar studies have performed: Other studies have shown success in monitoring the safety of similar treatments in lymphoma, indicating a precedent for this type of surveillance.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma Exclusion Criteria: * N/A
Where this trial is running
Japan
- Local Institution — Japan, Japan (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoma Nonhodgkin, Lymphoma, Nonhodgkin, low-grade, B-cell, Follicular, Marginal zone, Safety