A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia

A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia - A postmarketing all-case surveillance of mogamulizumab

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000025368

Enrollment

300

Registered

2016-12-22

Start date

2012-05-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who were treated with mogamuliumab, including mogamulizumab-retreated patients

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYukie Tsuji

Kyowa Kirin Co., Ltd. Pharmacovigilance Department

yukie.tsuji.dq@kyowakirin.com03-5205-7200

Outcome results