Clinical trial · Interventional
Endostar Aggressive Treatment of Peripheral T-cell Lymphoma (PTCL) Phase II Clinical Study
The Efficacy and Safety Research of Endostar Combined With GDP to Treat Aggressive Peripheral T-cell Lymphoma (PTCL) in Phase II Clinical Study.
NCT02520219CI-TRIAL-00018799unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphomas | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostar | Biological | — | UNRESOLVED |
| GDP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GDP+Endostar
- description
- 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.
- interventionNames
- Drug: GDP
- Biological: Endostar
- type
- ACTIVE_COMPARATOR
- label
- GDP
- description
- Patients in this group will be given conventional chemotherapy medicine: GDP (gemcitabine+dexamethasone+cis-platinum) chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma.
- interventionNames
- Drug: GDP
Primary outcomes (1)
- measure
- ORR(Overall release rate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed or relapsed PTCL patients by pathology, and / or cytology examination, which are required to receive chemotherapy; 2. At least 1 single size measurable lesions, CT, MRI, Bultrasound scan or PET-CT scan shows more than 15mm; 3. Physical condition is good: ECOG score between 0-2 points; 4. The expected survival time is more than 3 months; 5. Age 18 years or older,unlimited gender; 6. 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 7. No serious allergic reaction to biological agents, especially E. coli gene engineering products; 8. Voluntary participation, good compliance, cooperate with the experimental observation, and sign a written informed consent。 Exclusion Criteria: 1. Inert T cell lymphoma (such as mycosis fungoides /Sezary syndrome), ALK positive anaplastic large cell lymphoma; 2. Patients who received chemotherapy drugs in the past; 3. Pregnant women,lactating women,or having fertility but not taking contraceptive measures; 4. Patients with serious uncontroled acute infection;or suppurative and chronic infection and unhealing wound; 5. 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; 6. Patients with less control of the nervous, mental illness or mental disorders, poor compliance, and the description of the treatment response; 7. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system; 8. Patients with abnormal coagulation function and severe thrombosis; 9. Patients who participated in other clinical trials; 10. The researchers considered that patients should not be in this trial。
References
Publications (0)
Data not yet available
No reference posted for this study.