Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)

• Status: Unknown status
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 patients will be treated into this study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Fludarabine; Fludarabine phosphate; Liposomal doxorubicin; Vidarabine

Criteria

Inclusion Criteria:

1. 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-).

2. Aged 18~75.

3. Good performance status, ECOG score≤2. Estimated survival span >3 months

4. Previously untreated.

5. 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.

6. Good compliance and inform consenting

7. 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 Criteria:

1. 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.

2. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)

3. Severe uncontrolled underlying diseases

4. Pregnancy or lactation

5. Autoimmune disease history

6. Severe infection or metabolic diseases

7. Known allergic to multiple agents, including sulphanilamide.

8. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids

9. Lymphoma involving central nervous system