Primary objective of the study is to compare the efficacy and safety of decitabine plus CHOP (D-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL).
This is a randomized, multi-center, open-label study to compare efficacy and safety of D-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or decitabine plus CHOP (D-CHOP) administered in 4 week cycles for 6 cycles. In the D-CHOP arm, decitabine will be administered at a dose of 10 mg/m² IV on day 1-5 every 3 weeks. 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 3 cycles 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
100
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 3 years
Overall Survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 3 years
Response rate
complete response (CR) and partial response (PR) rates, using the standard response criteria (Cheson and al.)
Time frame: 3 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: 3 years
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1.4mg/m² iv on day 6
100mg/m² po on day6-10