Lymphoma
Conditions
Keywords
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
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
Interventions
DRUGRevlimid
Revlimid
Sponsors
Celgene
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Relapsed or Refractory Adult T-cell Leukemia Lymphoma
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Up to approximately 4 years | Number of participants with adverse events |
Countries
Japan
Outcome results
None listed