Trial of Endostar Combined With CHOPT for T Cell Lymphoma | NCT01430013

Studies
Trial of Endostar Combined With CHOPT for T Cell Lymphoma

NCT01430013

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Nov 4, 2015Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

T Cell Lymphoma

Interventions

Endostar and CHOPT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Nov 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2015

Last Update Posted Date

Nov 4, 2015Estimated

Name	Class
Simcere Pharmaceutical Co., Ltd	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endostar	Experimental	CHOPT chemotherapy plus Endostar	Drug: Endostar and CHOPT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endostar and CHOPT	Drug	Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone	Endostar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
safety of Endostar combined with CHOPT chemotherapy	Number of participants with adverse events as a measure of safety	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Huaqing wang, MD	Tianjin Medical University Cancer Institue and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Cancer Institute and Hospital		Tianjin	Tianjin Municipality	300060	China

Condition Browse Module

MeSH Terms

ID	Term
D016399	Lymphoma, T-Cell

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522911	endostar protein
D043169	Endostatins

Ancestor Terms

ID	Term
D043165	Angiostatic Proteins
D042501	Angiogenic Proteins
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided