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

Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy; T-Cell Lymphomas
• Intervention / Treatment: Drug: FAD

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
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaojian Liu, PhD; Phone Number: 8613816983809; Email: xiaojian_liu068@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer Hospital, FuDan University
      • Contact: Xiaojian Liu, PhD; Phone Number: 1107 8613816983809; Email: Xiaojian_liu068@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
side effects	1 months

Secondary Outcome Measures

Outcome Measure	Time Frame
PFS (progression free survival)	3 months
complete remission(CR)	2 months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Xiaonan Hong, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): November 1, 2010

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2010
• Last Update Submitted That Met QC Criteria: September 14, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Fludarabine; Peripheral T-cell lymphomas (PTCL)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fludarabine; Fludarabine phosphate; Vidarabine
• Other Study ID Numbers: 2007-71-143