Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
| Fudan University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a prospective , open, multicenter, randomized phase III study. We 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.
randomization Subjects will be randomly assigned to 1 of 2 treatment groups based on a computer-generated randomization schedule prepared before the study.
Dosage and administration
patients with bulky disease or extranodal lesion wil be received radiotherapy after finishing the chemotherapy.
Study evaluations
Clinical Safety Assessments
The following, safety, assessments and procedures will be performed according to the schedule of assessments:
A complete medical history (including demographics, smoking history, cancer/treatment history) will be performed at screening.
Physical examination*
ECG
Weight
Blood pressure
heart rate
respiratory rate
ECOG Score
Infection signs Adverse Events and Serious Adverse Events (SAEs) reported according to NCI-CTC criteria. Patients will be assessed for adverse events at each clinical visit and as necessary throughout the study.
The following will be completed according to the schedule of assessments:
Note:Adverse Events and Serious Adverse Events (SAEs) reported according to NCI-CTC criteria(Version 3.0)Patients will be assessed for adverse events at each clinical visit and as necessary throughout the study.
Adverse events and laboratory tests graded according to the NCI-CTC AE(Version 3).Adverse events will be assigned preferred terms and categorized into body systems according to the MEDDRA classification of the WHO terminology
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHOP | Active Comparator | 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. |
|
| c-ATT regimen | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy (CHOP) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | 5-year | |
| RR rate | 5year | |
| CR rate | 5year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guan ZhongZhen | Contact | 86-20-87343356 | tongyulin@hotmail.com | |
| Cheng-cheng Guo | Contact | 86-20-87343565 | guochch@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guan ZhongZhen | Sun Yat-Sen University Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tumor center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| chemotherapy(c-ATT) | Drug | 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. |
|
|
| PR rate | 5year |
| progression of disease rate | 5year |
| SAEs | 5year |
| quality of life | 5year |