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

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03098589
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 75.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: Revlimid

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma
• Actual Study Start Date: May 30, 2017
• Anticipated Primary Completion Date: Sep 27, 2023
• Anticipated Study Completion Date: Sep 27, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Adverse Events (AEs) [Up to approximately 4 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 Adult T-cell Leukemia Lymphoma

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ASO KK Iizuka Hospital	Iizuka	Fukuoka	Japan	820-8505

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: NCT03098589
• Other Study ID Numbers: NIS-Celgene-JP-PMS-004
• First Posted: Apr 4, 2017
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Celgene: Adult T-cell Leukemia Lymphoma; Teratogenicity; Myelosuppression; Haemorrhage; Infection; Thromboembolism; Hypersensitivity; Tumor lysis syndrome; Peripheral neuropathy; Ischaemic heart disease; Cardiac failure; Arrhythmia; Renal failure; Interstitial lung disease; Hepatic disorder; Hypothyroidism; Gastrointestinal perforation; Orthostatic hypotension; Convulsion; Somnolence; Confusion; Fatigue; Dizziness; Blurred vision; Second primary cancer; Cataract; Revlimid capsules
• Additional relevant MeSH terms: Lymphoma; Lenalidomide

Study Results

No Results Posted as of Jun 21, 2022