Brief Title
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
Official Title
Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
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 patients will be treated into this study.
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
side effects
Secondary Outcome
PFS (progression free survival)
Condition
T-Cell Lymphomas
Intervention
FAD
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
November 2007
Completion Date
November 2010
Primary Completion Date
November 2010
Eligibility 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Xiaonan Hong, MD, 8613816983809, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT00840385
Organization ID
2007-71-143
Study Sponsor
Fudan University
Study Sponsor
Xiaonan Hong, MD, Principal Investigator, Fudan University
Verification Date
September 2010