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

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ClinicalTrials.gov Identifier: NCT00840385
Recruitment Status : Unknown
Verified September 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : February 10, 2009
Last Update Posted : September 15, 2010
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 10, 2009
Last Update Posted Date September 15, 2010
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
side effects [ Time Frame: 1 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2009)
  • PFS (progression free survival) [ Time Frame: 3 months ]
  • complete remission(CR) [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • T-Cell Lymphomas
  • Chemotherapy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: A
Intervention: Drug: FAD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 9, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2010
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840385
Other Study ID Numbers  ICMJE 2007-71-143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaonan Hong, MD Fudan University
PRS Account Fudan University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP