CClinicalTrials.gg
Status unknownNCT00974324PTCLUpdated Sep 15, 2010

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

A Phase 2 interventional study of endostar and CHOP in T Cell Lymphoma, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-15.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • T Cell Lymphoma

Keywords

  • peripheral T cell lymphoma
  • chemotherapy
  • anti-angiogeneses
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 15 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    treatment

    endostar combined with CHOP regimen

    Drug: endostar and CHOP

Interventions

  • Drugendostar and CHOP

    endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

    Also known as: endostar

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. safety of endostar combined with CHOP

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Fudan University Cancer Hospital
    Shanghai, Shanghai 200032, China
    • Haiyi Guo, MD · Contact · guohaiyi@csco.org.cn · 86(021)64175590
    • Haiyi Guo, MD · Sub investigator
    • Junning Cao, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00974324
Lead sponsor
Fudan University
First posted
Sep 10, 2009
Start date
Aug 2009
Primary completion
Sep 2010 (estimated)
Completion
Sep 2011 (estimated)
Last update
Sep 15, 2010

Study contacts

Haiyi Guo, MD
Contact
guohaiyi@csco.org.cn
86(021)64175590 ext. 5008
Junning Cao, MD
principal investigator · Member of Fudan University Cancer Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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