Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
- Conditions
- previouly untreated advanced stage peripheral T-cell lymphoma
- Registration Number
- JPRN-UMIN000000829
- Lead Sponsor
- West Japan Hematology Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
(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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method Overall survival, Progression free survaval, adverse reaction/adverse effect