Status:
UNKNOWN
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
Lead Sponsor:
Fudan University
Conditions:
T-Cell Lymphomas
Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patient...
Detailed Description
Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment w...
Eligibility Criteria
Inclusion
- The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
- Aged 18\~75.
- Good performance status, ECOG score≤2. Estimated survival span \>3 months
- Previously untreated.
- At least 1 assessable disease (maximal diameter \>1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
- Good compliance and inform consenting
- Fit for the following criteria:
- Absolute neutrophil count (ANC)≥1.5×109/L
- Platelet（PLT）≥80×109/L
- Total bilirubin (TBI) ≤upper normal limit (UNL)
- Serum creatine (Cr) ≤UNL
- Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL
Exclusion
- Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
- Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
- Severe uncontrolled underlying diseases
- Pregnancy or lactation
- Autoimmune disease history
- Severe infection or metabolic diseases
- Known allergic to multiple agents, including sulphanilamide.
- Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
- Lymphoma involving central nervous system
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00840385
Start Date
November 1 2007
End Date
November 1 2010
Last Update
September 15 2010
Active Locations (1)
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1
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032