A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy.
Objective to evaluate the efficacy and safety of R-GDP (Rituximab, Gemcitabine, Dexamethasone, Cisplatin) plus PD-1 monoclonal antibody in patients with refractory or relapsed peripheral T cell lymphoma not otherwise specified or Angioimmunoblastic T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
375mg/m2 by IV infusion once every 3 weeks
1 g/m2 on Days 1 by IV infusion once every 3 weeks
40 mg on Days 1 to 4 of each 3-week cycle by IV infusion
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGObjective response rate (ORR)
Percentage of Complete remission (CR), and Partial remission (PR).
Time frame: 16 months
Progression-free survival (PFS)
Progression-free survival#PFS# is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause.
Time frame: 24 months
Overall survival (OS)
Overall survival#OS# is defined as the time from the date of enrollment to the date of death from any cause.
Time frame: 24 months
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time frame: 24 months
Serious Adverse Event (SAE)
A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes: 1. is fatal, is life-threatening 2. requires or prolongs inpatient hospitalization 3. results in persistent or significant disability/incapacity 4. constitutes a congenital anomaly or birth defect
Time frame: 24 months
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75 mg/m2 on Days 1 by IV infusion once every 3 weeks
200mg on Days 2 by IV infusion once every 3 weeks