Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)

Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL) - Phase II trial of combination therapy with arsenic trioxide/interferon/zidovudine and conventional chemothrapy for patients with adult T cell leukemia/lymphoma (ATL)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012268

Enrollment

Registered

2013-11-11

Start date

2013-11-11

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

Interventions

Conventional chemothrapy combined with arsenic trioxide/interferon/zidovudine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically proven T cell lymphoma 2) Anti-HTLV-1 antibody positive, Southern blotting proven HTLV-1 provirus clonality 3) acute type/lymphoma type/chronic type with poor prognosis factors 4) Performance status (PS) 0-3 5) untreated ATL 6) Conserved main organ function

Exclusion criteria

Exclusion criteria: 1) History of glaucoma 2) Poor control of diabetes mellitus 3) Coronary artery disease/cardiomyopathy/hear failure/arrhythmia 4) HIV antibody, HCV antibody, HBs antigen positive 5) Interstitial pneumonia, pulmonary fibrosis, severe emphysema 6) Acute hepatitis, chronic hepatitis, cirrhosis 7) Malignancy, malignant lymphoma, myelodysplastic syndrome, leukemia 8) Pregnancy 9) Psychological disease 10) History of allergy for arsenic trioxide/interferon/zidovudine

Design outcomes

Primary

Measure	Time frame
Three year overall survival	—

Secondary

Measure	Time frame
CR rate, CR+PR rate, safety	—

Countries

Japan

Contacts

Public ContactMakoto Yoshimitsu

Kagoshima University Hospital Department of Hematology and Immunology

myoshimi@m.kufm.kagoshima-u.ac.jp099-275-5934

Outcome results

None listed

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