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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00840385

Acronym

FAD

Enrollment

Registered

2009-02-10

Start date

2007-11-30

Completion date

2010-11-30

Last updated

2010-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy, T-Cell Lymphomas

Keywords

Peripheral T-cell lymphomas (PTCL), Fludarabine

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.

Interventions

DRUGFAD

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
side effects	1 months

Secondary

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

Countries

China

Contacts

Primary ContactXiaojian Liu, PhD

xiaojian_liu068@hotmail.com8613816983809

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026