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

Chemotherapy Clinical Trial

— FAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00840385
• Other study ID #: 2007-71-143
• Status: Recruiting
• Phase: Phase 2
• First received: February 9, 2009
• Last updated: September 14, 2010
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: September 2010
• Source: Fudan University
• Contact: Xiaojian Liu, PhD
• Phone: 8613816983809
• Email: xiaojian_liu068[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T-Cell Lymphomas

Intervention

Drug:
• FAD
Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.

Locations

Country	Name	City	State
China	Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	side effects		1 months	Yes
Secondary	PFS (progression free survival)		3 months	Yes
Secondary	complete remission(CR)		2 months	Yes