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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04618081
Other study ID # CC-5013-TCL-003
Secondary ID U1111-1260-3127
Status Recruiting
Phase
First received
Last updated
Start date December 18, 2020
Est. completion date March 27, 2025

Study information

Verified date January 2024
Source Celgene
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called. 1. Planned registration period 1.5 years 2. Planned surveillance period 3 years from the start of this survey


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date March 27, 2025
Est. primary completion date March 27, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Local Institution Japan

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events (AEs) Number of participants with adverse events Up to approximately 3 years