Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00974324
Other study ID # PTCL0908
Secondary ID
Status Recruiting
Phase Phase 2
First received September 9, 2009
Last updated September 14, 2010
Start date August 2009
Est. completion date September 2011

Study information

Verified date September 2010
Source Fudan University
Contact Haiyi Guo, MD
Phone 86(021)64175590
Email guohaiyi@csco.org.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
China Fudan University Cancer Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy include overall response rate, disease free survival and overall survival 1 year Yes
Secondary safety of endostar combined with CHOP 1 year Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04653649 - CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma. Phase 1/Phase 2
Not yet recruiting NCT06420076 - Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells Phase 1/Phase 2
Completed NCT01561833 - A Pilot Study of Sorafenib Examining Biomarkers in Refractory or Relapsed T-Cell Lymphoma Patients Phase 1
Withdrawn NCT04334174 - Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas Phase 2
Recruiting NCT05367856 - Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma Phase 2
Completed NCT00798096 - Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma Phase 2
Completed NCT03770000 - Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma Phase 1/Phase 2
Not yet recruiting NCT05996185 - Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma Phase 2
Active, not recruiting NCT01430013 - Trial of Endostar Combined With CHOPT for T Cell Lymphoma Phase 2
Active, not recruiting NCT04502446 - A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM) Phase 1
Terminated NCT04973527 - LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Phase 1
Recruiting NCT05230680 - Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS) Phase 1/Phase 2
Recruiting NCT03672084 - Allo-HSCT as First-line Consolidation in High-risk PTCL
Recruiting NCT05852028 - A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma
Enrolling by invitation NCT03628612 - Long-term Follow-up of Patients Treated With Autologous T Cells Genetically Modified Phase 2
Completed NCT00877656 - HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma Phase 2/Phase 3
Not yet recruiting NCT05772728 - Chidamide Combined With Azacitidine and Mitoxantrone Liposome in the Treatment of Relapsed/Refractory (nTFHL) N/A
Completed NCT01300026 - AMG 319 Lymphoid Malignancy FIH Phase 1
Terminated NCT00880867 - Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma Phase 1
Recruiting NCT04840875 - Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma Phase 1