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Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma (PTCL)

Primary Purpose

T Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endostar and CHOP
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T Cell Lymphoma focused on measuring peripheral T cell lymphoma, chemotherapy, anti-angiogeneses

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Disease Characteristics:

    • Diagnosis of peripheral T-cell:

      • Any stage disease allowed
    • At least 1 objective measurable disease parameter
    • No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma

      • ALK-negative T-cell large cell lymphoma allowed
    • No cutaneous T-cell lymphoma

      • No sezary syndrome
      • No NK/T cell lymphoma
    • No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement
  • Patient Characteristics:

    • Age:

      • 18 -75 years
    • Performance status:

      • ECOG 0-2
    • Life expectancy:

      • No less than 12 weeks
    • Hematopoietic:

      • Absolute neutrophil count ≥ 1,500/mm^3
      • Hemoglobulin ≥ 80*10^12/L
      • Platelet count ≥ 100,000/mm^3
      • No evidence of bleeding diathesis or coagulopathy
    • Hepatic:

      • Bilirubin ≤ 1.5 mg/dL
      • AST ≤ 2.5 times ULN
      • PT, INR, and PTT ≤ 1.5 times normal
    • Renal:

      • Creatinine ≤ 1.5 times normal
    • Cardiovascular:

      • No cerebrovascular accident within the past 6 months
      • No myocardial infarction within the past 6 months
      • No unstable angina within the past 6 months
      • No New York Heart Association class II-IV congestive heart failure
      • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg)
      • No other clinically significant cardiovascular or peripheral vascular disease
      • LVEF is normal
    • Other:

      • Not pregnant or nursing
      • Fertile patients must use effective contraception
      • No history of active seizures
      • No non-healing ulcer (unless involved with lymphoma)
      • No active infection requiring parenteral antibiotics
      • No known HIV positivity
      • No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • PRIOR CONCURRENT THERAPY:

    • Biologic therapy:

      • Not specified
    • Chemotherapy:

      • No prior chemotherapy was allowed
    • Surgery:

      • More than 4 weeks since prior major invasive surgery or open biopsy
      • At least 7 days since prior minor surgery
      • No concurrent major surgery

Exclusion Criteria:

  • Prior treatment included chemotherapy and radiotherapy
  • With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
  • Pregnant or nursing
  • Other currently active malignancy except nonmelanoma skin cancer
  • Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
  • Hypersensitivity to albumen

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

endostar combined with CHOP regimen

Outcomes

Primary Outcome Measures

efficacy include overall response rate, disease free survival and overall survival

Secondary Outcome Measures

safety of endostar combined with CHOP

Full Information

First Posted
September 9, 2009
Last Updated
September 14, 2010
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT00974324
Brief Title
Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
Acronym
PTCL
Official Title
Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The role of angiogenesis has been less clear in lymphoma than in solid tumors, in part related to the heterogeneity of disease and technical issues. In addition to vascular endothelial growth factor (VEGF) effects on angiogenesis and the integrity of tumor vasculature, autocrine VEGF-receptor (VEGF-R)-mediated signaling may play a role in lymphoma. Microvessel density, a measure of angiogenesis, is highest in peripheral T-cell lymphomas (PTCL), followed by diffuse large B-cell (DLBCL) and intra-follicular follicular lymphoma (FL).
Detailed Description
To investigate efficacy and safety of endostar combined with CHOP regimen as first line treatment for peripheral T cell lymphoma.The second subject is to clarify the association between expression of VEGF and prognosis in peripheral T cell lymphoma,unspecified(PTCL-U) and angioimmunoblastic T-cellLymphoma(AILT).Methods 15 cases of PTCL were enrolled in this study.Immunohistochemical staining was performed by EnVision method using antibodies VEGF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
Keywords
peripheral T cell lymphoma, chemotherapy, anti-angiogeneses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
endostar combined with CHOP regimen
Intervention Type
Drug
Intervention Name(s)
endostar and CHOP
Other Intervention Name(s)
endostar
Intervention Description
endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone
Primary Outcome Measure Information:
Title
efficacy include overall response rate, disease free survival and overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety of endostar combined with CHOP
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disease Characteristics: Diagnosis of peripheral T-cell: Any stage disease allowed At least 1 objective measurable disease parameter No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma ALK-negative T-cell large cell lymphoma allowed No cutaneous T-cell lymphoma No sezary syndrome No NK/T cell lymphoma No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement Patient Characteristics: Age: 18 -75 years Performance status: ECOG 0-2 Life expectancy: No less than 12 weeks Hematopoietic: Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobulin ≥ 80*10^12/L Platelet count ≥ 100,000/mm^3 No evidence of bleeding diathesis or coagulopathy Hepatic: Bilirubin ≤ 1.5 mg/dL AST ≤ 2.5 times ULN PT, INR, and PTT ≤ 1.5 times normal Renal: Creatinine ≤ 1.5 times normal Cardiovascular: No cerebrovascular accident within the past 6 months No myocardial infarction within the past 6 months No unstable angina within the past 6 months No New York Heart Association class II-IV congestive heart failure No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg) No other clinically significant cardiovascular or peripheral vascular disease LVEF is normal Other: Not pregnant or nursing Fertile patients must use effective contraception No history of active seizures No non-healing ulcer (unless involved with lymphoma) No active infection requiring parenteral antibiotics No known HIV positivity No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy was allowed Surgery: More than 4 weeks since prior major invasive surgery or open biopsy At least 7 days since prior minor surgery No concurrent major surgery Exclusion Criteria: Prior treatment included chemotherapy and radiotherapy With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) Pregnant or nursing Other currently active malignancy except nonmelanoma skin cancer Uncontrolled or severe bleeding,diarrhea,intestinal obstruction Hypersensitivity to albumen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyi Guo, MD
Phone
86(021)64175590
Ext
5008
Email
guohaiyi@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junning Cao, MD
Organizational Affiliation
Member of Fudan University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyi Guo, MD
Phone
86(021)64175590
Ext
5008
Email
guohaiyi@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Haiyi Guo, MD
First Name & Middle Initial & Last Name & Degree
Junning Cao, MD

12. IPD Sharing Statement

Learn more about this trial

Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma

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