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

UMIN ID: UMIN000000829

Registered date:22/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: previouly untreated advanced stage peripheral T-cell lymphoma
• Date of first enrollment: 2007/08/01
• Target sample size: 42
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy (8 courses of EPOCH)

Outcome(s)

• Primary Outcome: Complete response rate
• Secondary Outcome: Overall survival, Progression free survaval, adverse reaction/adverse effect

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 79years-old
• Gender: Male 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 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

Related Information

• Primary Sponsor: West Japan Hematology Oncology Group
• Source(s) of Monetary Support: West Japan Hematology Oncology Group