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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
T-Cell Lymphomas Chemotherapy | Drug: FAD | Phase 2 |
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:
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- side effects [ Time Frame: 1 months ]
- PFS (progression free survival) [ Time Frame: 3 months ]
- 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 |
Inclusion Criteria:
- 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-).
- Aged 18~75.
- Good performance status, ECOG score≤2. Estimated survival span >3 months
- Previously untreated.
- 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.
- Good compliance and inform consenting
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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:
- 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.
- Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
- Severe uncontrolled underlying diseases
- Pregnancy or lactation
- Autoimmune disease history
- Severe infection or metabolic diseases
- Known allergic to multiple agents, including sulphanilamide.
- Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
- Lymphoma involving central nervous system

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
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 |
Principal Investigator: | Xiaonan Hong, MD | Fudan University |
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 |
Peripheral T-cell lymphomas (PTCL) Fludarabine |
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 |