Endostar Aggressive Treatment of Peripheral T-cell Lymphoma (PTCL) Phase II Clinical Study

NCT02520219 | Unknown Phase 2 DMC

• 1 other identifier: Endostar-PTLC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human recombinant endostatin injection）combined with traditional GDP （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.

Conditions

Peripheral T-cell Lymphomas

Keywords

Peripheral T-cell lymphomas,Endostar

Outcome Measures

Primary Outcomes (1)

• ORR(Overall release rate)

  According to the Cheson standard recommended by NCCN (National Comprehensive Cancer Network)guidelines of USA, the evaluation of the clinical effect of the drug on tumor was evaluated by comparing the change of tumor size and duration.

  Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Secondary Outcomes (5)

• PFS（progression-free survival）

  Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

• DCR(disease control rate)

  Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

• OS（overall survival）

  Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

• Adverse reaction

  Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase

• The quality of life（QOL） Questionnaire

  Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

Study Arms (2)

GDP+Endostar

EXPERIMENTAL

Patients in this group will be given conventional chemotherapy medicine: GDP (gemcitabine+dexamethasone+cis-platinum)chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma and Endostar.

Drug: GDP; Biological: Endostar

GDP

ACTIVE COMPARATOR

Patients in this group will be given conventional chemotherapy medicine: GDP (gemcitabine+dexamethasone+cis-platinum) chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma.

Drug: GDP

Interventions

GDP DRUG

GDP is a a combination therapy,repeated every 21 days. GEM(gemcitabine)1000mg/m2,ivgtt,30,d1、8; DXM(dexamethasone),40mg/d,p.o,d1-4; DDP(cis-platinum),75mg/m2,ivgtt,\>1h,d1; or DDP25 mg/m2,ivgtt,\>1h,d1-3.

GDP; GDP+Endostar

Endostar BIOLOGICAL

Endostar is a continuous intravenous injection pump, continuous intravenous pumped by seven consecutive days,d1- d7, which is 168 hours .Endostar pumping well dose is 30 mg every 24 hours. Repeated every 21 days.

GDP+Endostar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed or relapsed PTCL patients by pathology, and / or cytology examination, which are required to receive chemotherapy;
• At least 1 single size measurable lesions, CT, MRI, Bultrasound scan or PET-CT scan shows more than 15mm；
• Physical condition is good: ECOG score between 0-2 points；
• The expected survival time is more than 3 months；
• Age 18 years or older,unlimited gender；
• Fit chemotherapy indications and basic requirements, including normal peripheral hemogram,no obvious abnormal function of heart, liver and kidney, normal ECG;no great trauma without healing；
• The test indicators must fit the following requirements:
• Cardiac ultrasound LVEF≥50%； Peripheral blood：WBC≥3.5×109/L，PLT≥70×109/L，Hb≥80g/L Renal function：Cr≤2.0×UNL（Upper limit of normal value） Liver function：BIL≤2.0×UNL，ALT/AST≤2.5×UNL
• No serious allergic reaction to biological agents, especially E. coli gene engineering products；
• Voluntary participation, good compliance, cooperate with the experimental observation, and sign a written informed consent。

You may not qualify if:

• Inert T cell lymphoma (such as mycosis fungoides /Sezary syndrome), ALK positive anaplastic large cell lymphoma；
• Patients who received chemotherapy drugs in the past;
• Pregnant women,lactating women,or having fertility but not taking contraceptive measures；
• Patients with serious uncontroled acute infection;or suppurative and chronic infection and unhealing wound；
• Patients with original serious heart disease, including: high-risk cardiac arrhythmias of congestive heart failure,uncontroled instability angina, myocardial infarction and severe heart valve disease and intractable hypertension；
• Patients with less control of the nervous, mental illness or mental disorders, poor compliance, and the description of the treatment response；
• Patients with primary central nervous system lymphoma or lymphoma involving central nervous system；
• Patients with abnormal coagulation function and severe thrombosis;
• Patients who participated in other clinical trials；
• The researchers considered that patients should not be in this trial。

Sponsors & Collaborators

• Nanjing NingQi Medicine Science and Technology Co., Ltd.: lead
• Jiangsu Cancer Institute & Hospital: collaborator

Study Sites (1)

Jiangsu province tumor hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Guanosine Diphosphate; endostar protein

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guanine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Yin Qingfeng, manager

CONTACT

0086-025-85632992; y_qingfeng@163.com

Zhou Xiaolei, sponsor

CONTACT

0086-02585566666; zhouxiaolei@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: August 11, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

CN (1)