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

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04618081
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Anticipated Duration (Months): 29.4
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Nonhodgkin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 110 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)
• Actual Study Start Date: Dec 18, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Adverse Events (AEs) [Up to approximately 3 years]

   Number of participants with adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Japan		Japan

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT04618081
• Other Study ID Numbers: CC-5013-TCL-003; U1111-1260-3127
• First Posted: Nov 5, 2020
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Lymphoma; Nonhodgkin; low-grade; B-cell; Follicular; Marginal zone; Safety; Revlimid; Rituximab; Actual use conditions; R2 combination therapy; Bone marrow depression; Neutropenia; Tumor flare
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Jun 23, 2022