The goal of this observational study is to evaluate the safety and efficacy of Go-CHOP (Golidocitinib plus Cyclophosphamide, Hydroxydoxorubicin, Oncovin and Prednisone) in de novo intestinal T-cell lymphoma patients, The aim is to evaluate the complete response rate (CRR). Participants will receive Go-CHOP for 6 cycles every 21 days followed by either maintenance therapy or ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Induction Treatment: Golidocitinib:150mg QD Cyclophosphamide:750mg/m2,d1 vincristine:1.4mg/m2,d1(max 2mg) doxorubicin:50mg/m2,d1 Prednisone:60mg/m2 (max 100mg),d1-d5 Every 21 days
Maintenance Treatment: Complete remission patients will further divide into two groups. Unfit, frail old patients will receieve Golidocitinib 150mg QD for two years. Fit, young patients will receive ASCT.
Complete Response Rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of Cycle 6 (each cycle is 21days)
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Objective Response Rate
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of Cycle 6 (each cycle is 21days)
Duration of Response
Applicable to complete or partial response participants. DoR was defined as the time from the first documented date of complete or partial response until the date of the disease progression or death from any causes.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Overall survival
Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: Baseline up to data cut-off(up to approximately 3 years)
Adverse Events
Adverse Events are assessed based on CTCAE v5.0
Time frame: Baseline up to data cut-off(up to approximately 3 years)
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