Peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. Consecutive new diagnoses with measurable disease representing histologically documented PTCL-nos or AITL according to the World Health Organization classification; b. pre-study performance status PS score ranging from 0 to 3 on the Eastern Cooperative Oncology Group; c. 15-69 years of age; d. any clinical stage; e. knowledge about their diagnosis and expected prognosis f. a left ventricular ejection fraction by echocardiography at least 50% g. a partial pressure of oxygen in the arterial blood at least 60 Torr while breathing ambient air. h. written informed conscent
Exclusion criteria
Exclusion criteria: Exclusion criteria were the presence of serious infection; active tuberculosis; diabetes mellitus uncontrollable with insulin, liver cirrhosis, arrhythmia, or other abnormal electrocardiographic finding requiring treatment, concomitant malignant disease other than basal cell carcinoma of the skin or carcinoma in situ of the uteric cervix; central nervous system (CNS) lymphoma; pregnancy or breast feeding; mental disorders; and positivity for hepatitis B surface antigen, human T-lymphotrophic virus-1 antibody, or human immunodeficiency virus antibody. Patients were also excluded if the treating physician considered the protocol too difficult for the patients to carry out.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate and safety | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival and overall survival | — |
Countries
Japan