Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
T-Cell Lymphomas, Chemotherapy

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Trial Information

Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL


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 with standard doxorubicin containing regimens. There is general
agreement that results with conventional chemotherapy are so poor in patients with most PTCL
that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with
other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by
others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine,
Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed
PTCL.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

side effects

Outcome Time Frame:

1 months

Safety Issue:

Yes

Principal Investigator

Xiaonan Hong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

2007-71-143

NCT ID:

NCT00840385

Start Date:

November 2007

Completion Date:

November 2010

Related Keywords:

  • T-cell Lymphomas
  • Chemotherapy
  • Peripheral T-cell lymphomas (PTCL)
  • Fludarabine
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

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