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

NCT04618081 | Completed

• 2 other identifiers: CC-5013-TCL-003U1111-1260-3127
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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. 1.Planned registration period 1.5 years
2. 2.Planned surveillance period 3 years from the start of this survey

Conditions

Lymphoma Nonhodgkin

Keywords

Lymphoma; Nonhodgkin; low-grade; B-cell; Follicular; Marginal zone; Safety; Revlimid; Rituximab; Actual use conditions; R2 combination therapy; Bone marrow depression; Neutropenia; Tumor flare

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse events

  Up to approximately 3 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

You may not qualify if:

• N/A

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution

Japan, Japan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Bone Marrow Failure Disorders; Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Hematologic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 5, 2020
• Study Start: December 17, 2020
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (1)