A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
Phase 4
- Conditions
- CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma
- Registration Number
- JPRN-UMIN000025368
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
In the safety analysis population, adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion-related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 597
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Safety (1)Occurrence of ADRs (e.g., types and incidence) (2)Evaluation on factors likely to affect safety (3)Occurrence of serious adverse events (4)Occurrence of priority survey items (infusion-related reactions, skin disorders, infections and immune disorders, and tumor lysis syndrome) 2.Efficacy (1)Response rate (by attending physician) (2)Survival rate at 31 weeks after treatment initiation
- Secondary Outcome Measures
Name Time Method