A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)

A phase II study of Bortezomib for relapsed/refractory adult T-cell leukemia/lymphoma (ATL) - A phase II study of Bortezomib for ATL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004061

Enrollment

Registered

2010-08-18

Start date

2010-08-01

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

Adult T-cell Leukemia/Lymphoma (ATL)

Interventions

Treatment by Bortezomib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Relapsed or refractory ATL patients after one or more prior lines of chemotherapy under the diagnosis of ATL (acute type, lymphoma type, or chronic type with unfavorable factor). 2) Aged 20 years old or older 3) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale 4) More than 4 weeks of interval from last chemotherapy for ATL to scheduled first day of protocol treatment. 5) Having a measurable lesion, or evaluable lesions either of peripheral blood or skin. 6) Adequate hematological and major organ function 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of treatment by bortezomib 2) Hypersensitivity to bortezomib, mannitol or boron. 3) History of administration of other investigational agents within 4 weeks before informed consent. 4) Interstitial pneumonia or pulmonary fibrosis. 5) Class III or IV (NYHA) cardiac disease, and/or either of cardiac infarction within 6 months before the informed consent, uncontrollable angina, severe ventricular arrhythmia, acute coronary ischemia, or symptomatic conduction block 6) Active infection 7) Suspicious findings of central nervous invasion 8) Grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 9) Either of cardiac failure, renal failure, hepatic failure, uncontrollable hypertension or uncontrollable diabetes mellitus. 10) Psychological disturbance 11) Synchronous or metachronous malignancy 12) HBs-Ag positive or HBc-Ab positive with HBV-DNA positive 13) HCV-Ab positive, HIV positive 14) Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Overall best response	—

Secondary

Measure	Time frame
Safety, best response in each lesion, progression free survival, serum LDH, serum soluble IL-2 receptor, and HTLV-1 provirus DNA in PBMNCs	—

Countries

Japan

Contacts

Public ContactKenji Ishitsuka

PS341-ATL Coordinating Office Division of Oncology, Hematology and Infectious Disease, Fukuoka University

kenjiishitsuka@fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026