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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

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.

Condition or disease Intervention/treatment Phase
T-Cell Lymphomas Chemotherapy Drug: FAD Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
Study Start Date : November 2007
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. side effects [ Time Frame: 1 months ]

Secondary Outcome Measures :
  1. PFS (progression free survival) [ Time Frame: 3 months ]
  2. complete remission(CR) [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840385


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

Locations
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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
Investigators
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Principal Investigator: Xiaonan Hong, MD Fudan University
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Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00840385    
Other Study ID Numbers: 2007-71-143
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010
Keywords provided by Fudan University:
Peripheral T-cell lymphomas (PTCL)
Fludarabine
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vidarabine
Fludarabine
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents