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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04618081

Enrollment

151

Registered

2020-11-05

Start date

2020-12-17

Completion date

2025-03-27

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion criteria

* N/A

Design outcomes

Primary

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

Countries

Japan

Outcome results