NCT01430013

Brief Summary

To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.

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 Jun 2011

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

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

September 1, 2011

Enrollment Period

4.4 years

First QC Date

July 11, 2011

Last Update Submit

November 2, 2015

Conditions

T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • efficacy including overall response rate, progression free survival and overall survival

    According to International Workshop Criteria, the number of participants with complete remission, partial remission and stable disease as a measure of efficacy.progressive free survival and overall survival of the participants are the second measure of efficacy

    1 year

Secondary Outcomes (1)

  • safety of Endostar combined with CHOPT chemotherapy

    1 year

Study Arms (1)

Endostar

EXPERIMENTAL

CHOPT chemotherapy plus Endostar

Drug: Endostar and CHOPT

Interventions

Endostar and CHOPTDRUG

Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone

Also known as: Endostatin
Endostar

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged 18 to 70 years old.
  • Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
  • At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
  • Eastern Cooperative Oncology Group status 0-2
  • White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
  • Alanine transaminase (ALT) ≤2×upper limit of normal(ULN); Aspartate transaminase (AST) ≤2×ULN; Total Bilirubin≤1.5×ULN; Creatinine in normal range

You may not qualify if:

  • No active central nervous system lymphoma or brain tumor
  • Suppurative inflammation,Chronic infection
  • Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
  • psychiatric history
  • Primary cutaneous T cell lymphoma
  • Pregnant or lactating women
  • Concurrent treatment with another investigational agent
  • Accept radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

endostar proteinEndostatins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Huaqing wang, MD

    Tianjin Medical University Cancer Institue and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 11, 2011

First Posted

September 7, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

November 4, 2015

Record last verified: 2011-09

Locations

CN(1)