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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was  Recruiting
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
First received: February 9, 2009
Last updated: September 14, 2010
Last verified: September 2010
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.

Condition Intervention Phase
T-Cell Lymphomas
Drug: FAD
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • side effects [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PFS (progression free survival) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • complete remission(CR) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: FAD
Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.
Other Names:
  • Fludarabine phosphate
  • oral fludarabine

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00840385

Contact: Xiaojian Liu, PhD 8613816983809 xiaojian_liu068@hotmail.com

China, Shanghai
Cancer Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xiaojian Liu, PhD    8613816983809 ext 1107    Xiaojian_liu068@hotmail.com   
Sponsors and Collaborators
Fudan University
Principal Investigator: Xiaonan Hong, MD Fudan University
  More Information

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00840385     History of Changes
Other Study ID Numbers: 2007-71-143 
Study First Received: February 9, 2009
Last Updated: September 14, 2010
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Peripheral T-cell lymphomas (PTCL)

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Fludarabine phosphate
Liposomal doxorubicin
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016