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

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

Tracking Information

• First Submitted Date: February 9, 2009
• First Posted Date: February 10, 2009
• Last Update Posted Date: September 15, 2010
• Study Start Date: November 2007
• Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 9, 2009): side effects [ Time Frame: 1 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 9, 2009)

• PFS (progression free survival) [ Time Frame: 3 months ]
• complete remission(CR) [ Time Frame: 2 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• T-Cell Lymphomas
• Chemotherapy

Intervention

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

Experimental: A

Intervention: Drug: FAD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2009): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2010
• Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00840385
• Other Study ID Numbers: 2007-71-143
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
• Study Sponsor: Fudan University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xiaonan Hong, MD; Fudan University

• PRS Account: Fudan University
• Verification Date: September 2010