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T Cell LymphomaPhase 2PTCLNCT00974324

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

A Phase 2 study testing endostar and CHOP in people with T Cell Lymphoma, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
T Cell Lymphoma
What is being tested?
endostar and CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
Aug 2009to Sep 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Haiyi Guo, MD contact

86(021)64175590 ext. 5008

guohaiyi@csco.org.cn

China1 site, 1 recruiting

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

    Haiyi Guo, MD, 86(021)64175590 ext. 5008, guohaiyi@csco.org.cn

    Haiyi Guo, MD

    Recruiting

Other trials in China

About this study

Official title: Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma

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.

Conditions
T Cell Lymphoma
Being tested
endostar and CHOP
Keywords
peripheral T cell lymphoma, chemotherapy, anti-angiogeneses
Medical subject headings
Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endostar and CHOPDrug

    Also called endostar

    endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks

    CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone

Study groups in NCT00974324
Study groupRoleWhat they receive
treatmentExperimentalendostar combined with CHOP regimen
Receives: Drug: endostar and CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Secondary outcomes (1)

  1. safety of endostar combined with CHOP

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionSep 2010 (estimated)
  4. Study completionSep 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974324
Sponsor's protocol ID
PTCL0908
Acronym
PTCL
Status last verified
Sep 2010
First submitted
9 Sep 2009
Last updated
15 Sep 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing endostar and CHOP in people with T Cell Lymphoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 53 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haiyi Guo, MD (86(021)64175590 ext. 5008, guohaiyi@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy include overall response rate, disease free survival and overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2010; AzTrials last refreshed its copy on 6 Nov 2026.

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