This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.
Patients with transformed DLBCL lack standard treatment. We intend to conduct a prospective, multicenter, phase II study in order to evaluate efficacy and safety of POLA-R-CHP as first-line treatment of patients with transformed DLBCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING2-year progression-free survival (PFS) assessed by imaging examination
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
complete remission rate assessed by imaging examination
the ratio of numbers of patients with complete response after 6 treatment cycles to all the participants
Time frame: up to 6 months
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Time frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival rate
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Through study completion, up to 2 years
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