Clinical trial · Interventional
A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients
A Prospective , Multicenter, RandomizedPhase III Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients
NCT01788137CI-TRIAL-00020168unknownPhase 3ClinicalTrials.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)
This is a prospective , open, multicenter, randomized phase III study. The investigators planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk | — | UNRESOLVED | — |
| Previously Untreated | — | UNRESOLVED | — |
| T-cell Lymphoma Adults | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy(c-ATT) | Drug | Chemotherapy | ALIAS |
| chemotherapy (CHOP) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CHOP
- description
- CHOP regimen Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles.
- interventionNames
- Drug: chemotherapy (CHOP)
- type
- ACTIVE_COMPARATOR
- label
- c-ATT regimen
- description
- c-ATT regimen Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.
- interventionNames
- Drug: chemotherapy(c-ATT)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 and ≤70 years old. * Histological documented high risk T cell lymphoma:extranodal NK/T-cell lymphoma,hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma,angioimmunoblastic T-cell lymphoma,enteropathy-type T-cell lymphoma, peripheral T-cell lymphoma,unspecified. * Measurable disease and evaluable lesion. * Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease. * Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L) * ECOG Performance status 0-3,Life expectancy of at least 3 months. * Without history of another malignancy * Without any conflict serious systemic disease * Without any accompany treatment(including steroids drugs) * Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. * Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening. Exclusion Criteria: * Patients with prior clinical study within 3 months. * Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy * Transformed lymphoma * Mycosis fungicide/Sézary syndrome（MF/SS） * History of allergic reaction to any ectogenic proteins * Prior treatment for lymphoma . * History of another malignancy * Neutrophil count \< 1.0× 109/L ,hemoglobin \< 90g/L,platelets \< 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection. * Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months * Serious infective or organic disease * Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal) * liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl) * clinical syndrome of encephalon functional disorder,serious psychosis * female subject who is pregnant or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.