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

NCT ID: NCT04618081

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2025-03-27

Brief Summary

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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

Detailed Description

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Conditions

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Lymphoma Nonhodgkin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Japan, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1260-3127

Identifier Type: REGISTRY

Identifier Source: secondary_id

CC-5013-TCL-003

Identifier Type: -

Identifier Source: org_study_id

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