NCT00840385

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

3 years

First QC Date

February 9, 2009

Last Update Submit

September 14, 2010

Conditions

T-Cell LymphomasChemotherapy

Keywords

Peripheral T-cell lymphomas (PTCL)Fludarabine

Outcome Measures

Primary Outcomes (1)

  • side effects

    1 months

Secondary Outcomes (2)

  • PFS (progression free survival)

    3 months

  • complete remission(CR)

    2 months

Study Arms (1)

A

EXPERIMENTAL
Drug: FAD

Interventions

FADDRUG

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

Also known as: Fludarabine phosphate, oral fludarabine
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-CellLymphoma, T-Cell, Peripheral

Interventions

Flavin-Adenine Dinucleotidefludarabine phosphatefludarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

RiboflavinFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAdenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesPigments, BiologicalBiological Factors

Study Officials

  • Xiaonan Hong, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojian Liu, PhD

CONTACT

8613816983809xiaojian_liu068@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

November 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations

CN(1)