Revlimid® Capsules General Drug Use-results Surveillance (Relapsed or Refractory FL and MZL)

Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)

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

Study Overview

• Status: Completed
• Conditions: Lymphoma Nonhodgkin

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Japan
  • Japan, Japan
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This survey will be conducted in patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who receive R2 combination therapy with the drug and rituximab for the first time.

Description

Inclusion Criteria:

- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with FL or MZL; Patients who have been diagnosed with follicular lymphoma (FL) or marginal zone lymphoma (MZL) who receive R2 combination therapy with revlimid and rituximab for the first time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Number of participants with adverse events	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: October 31, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Lymphoma; Rituximab; B-cell; Revlimid; Neutropenia; Follicular; low-grade; Nonhodgkin; Marginal zone; Actual use conditions; R2 combination therapy; Bone marrow depression; Tumor flare
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: CC-5013-TCL-003; U1111-1260-3127 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No