Unique ID issued by UMIN | UMIN000000829 |
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Receipt number | R000000996 |
Scientific Title | Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma |
Date of disclosure of the study information | 2007/09/22 |
Last modified on | 2018/09/29 12:57:37 |
Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
Dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
Japan |
previouly untreated advanced stage peripheral T-cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety and efficacy of dose-adjusted EPOCH therapy for the previously untreated patients of advanced peripheral T-cell lymphoma
Safety,Efficacy
Exploratory
Phase II
Complete response rate
Overall survival, Progression free survaval, adverse reaction/adverse effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Chemotherapy (8 courses of EPOCH)
15 | years-old | <= |
79 | years-old | >= |
Male and Female
(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
42
1st name | |
Middle name | |
Last name | Mitsune Tanimoto, M.D., Ph.D., Professor & Chairman |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Department of Hematology, Oncology, and Respiratory Medicine
2-5-1 Shikata-cho, Okayama 700-8558
086-235-7227
tanimoto@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshinobu Maeda, M.D., Ph.D. |
Okayama University Hospital
Department of Hematology and Oncology
2-5-1 Shikata-cho, Okayama 700-8558
086-235-7227
yosmaeda@md.okayama-u.ac.jp
West Japan Hematology Oncology Group
West Japan Hematology Oncology Group
Self funding
NO
2007 | Year | 09 | Month | 22 | Day |
Unpublished
Completed
2007 | Year | 07 | Month | 18 | Day |
2007 | Year | 08 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2007 | Year | 09 | Month | 21 | Day |
2018 | Year | 09 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000996
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