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CompletedNCT04618081Updated Jul 8, 2025

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

An observational study in Lymphoma Nonhodgkin, sponsored by Celgene. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Celgene · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
151
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • 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
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 151 is close to the median of 150 across 159 observational studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
151 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Number of participants with adverse events

    Time frame: Up to approximately 3 years

07

Study locations

1 site
  • Local Institution
    Japan, Japan
08

References and documents

Individual participant data

Plan to share: Yes — 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/

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04618081
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Nov 5, 2020
Start date
Dec 17, 2020
Primary completion
Mar 27, 2025
Completion
Mar 27, 2025
Last update
Jul 8, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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