NIPH Clinical Trials Search

UMIN ID: UMIN000000829

Registered date:22/09/2007

Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedpreviouly untreated advanced stage peripheral T-cell lymphoma
Date of first enrollment2007/08/01
Target sample size42
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy (8 courses of EPOCH)


Primary OutcomeComplete response rate
Secondary OutcomeOverall survival, Progression free survaval, adverse reaction/adverse effect

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum79years-old
GenderMale and Female
Include 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.
Exclude criteria1) 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

Related Information


public contact
Name Yoshinobu Maeda, M.D., Ph.D.
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7227
Affiliation Okayama University Hospital Department of Hematology and Oncology
scientific contact
Name Mitsune Tanimoto, M.D., Ph.D., Professor & Chairman
Address 2-5-1 Shikata-cho, Okayama 700-8558 Japan
Telephone 086-235-7227
Affiliation Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science Department of Hematology, Oncology, and Respiratory Medicine