Primary objective of the study is to compare the efficacy and safety of CDOP versus CHOP for newly diagnosed peripheral T-cell lymphoma (PTCL).
This is a open-label, multi-center, randomized, non-inferiority study to compare efficacy and safety of CDOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven newly diagnosed PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 2 cycles, 4cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
750mg/m² ivgtt on day 1
40mg/m² ivgtt on day 1
1.4mg/m²(Maximum 2 mg) ivgtt on day 1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
RECRUITINGResponse rate
complete response (CR) and partial response (PR) rates, using the standard response criteria
Time frame: 2 years
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 2 years
Overall Survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 2 years
Cardiac toxicity
cardiotoxity Congestive heart failure with clinical symptoms, or no symptoms but an abnormal LVEF
Time frame: 2 years
Adverse Events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: 2 years
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Prednisone100mg/m² po on day1-5
50mg/m² ivgtt on day 1