previouly untreated advanced stage peripheral T-cell lymphoma
Conditions
Interventions
Chemotherapy (8 courses of EPOCH)
Sponsors
West Japan Hematology Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histological confirmed Anaplastic large cell lymphoma (ALCL) or Angioimmunoblastic T-cell lymphoma (AILT) or Peripheral T-cell lymphoma, unspecified (PTCL-u). (2) Clinical stage of II, III, IV by Ann Arbor classification. (3) Bidimensionally measurable disease (4) Age: between 15 and 79. (5) Performance Status: between 0 and 2. (6) No organ dysfuction; neutrophil count >=1000/ml, platelet count >=75000/ml, ASTand ALT level <=3 times the upper limit of the normal range, total bilirubin level <= 2.0 mg/dl, serum creatinin level <= 2.0mg/dl, Resting ejection fraction >= 50% by UCG. SaO2 >=90% or PaO2 >=60 mmHg in room air. (7) No prior chemotherapy, radiotherapy (8) Understanding and agreement of written informed consent.
Exclusion criteria
Exclusion criteria: 1) Uncontrollable active infection 2) Complication; uncontrollable hypertension or DM, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis. 3) Positive for HIV antibody or HBs antigen. 4) Have an active cancer. 5) Pregnant or nursing. 6) Psycological disorder like schizophrenia. 7) A patient who was judged as inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survaval, adverse reaction/adverse effect | — |
Countries
Japan
Outcome results
None listed