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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.
Full description
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
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Interventional model
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380 participants in 2 patient groups
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Central trial contact
Cheng-cheng Guo; Guan ZhongZhen
Data sourced from clinicaltrials.gov
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