Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

June 17, 2022 updated by: Celgene

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

  1. Planned registration period 3 years
  2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Japan
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-8505
        • Recruiting
        • ASO KK Iizuka Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Among patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as "Adult T-cell Leukemia Lymphoma (ATLL)") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).

Description

Inclusion Criteria:

- Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with T-cell leukemia lymphoma treated with Revlimid
Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance
Drug: Revlimid
Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Up to approximately 4 years
Number of participants with adverse events
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Anticipated)

September 27, 2023

Study Completion (Anticipated)

September 27, 2023

Study Registration Dates

First Submitted

March 28, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-Celgene-JP-PMS-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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