This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma
This is an open, multicenter, prospective phase I/II clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m², 18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen, with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2
375mg/m2, D2
750mg/m2, D2
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGPhase I:Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in R-CMOP
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Phase I: Recommended phaseII dose (RP2D)
The Recommended Phase II Dose (RP2D) is defined as the optimal dose of liposomal mitoxantrone hydrochloride for use in Phase II trials, as determined by the outcomes of the Phase I study.
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Phase II:Complete remission rate (CRR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Phase I: Dose limited toxicities (DLTs)
adverse events defined as DLT events per protocol
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Phase I: The incidence rates of adverse events (AEs)
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Time frame: up to 2 years
Phase I: Objective response rate (ORR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Phase I: Complete remission rate (CRR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
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1.2mg/m2, maximum 2mg, D2
60mg/m2, D2-6
Phase II: Overall response rate (ORR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Phase II: Partial response rate (PRR)
Response is assessed according to the lugano criteria
Time frame: up to 2 years
Phase II: Duration of response (DOR)
DOR was defined as the time from first complete response or partial response to disease progression or death from any causes.
Time frame: up to 2 years
Phase II: Progression-free survival (PFS)
From the date of the first dose of therapy is given until disease progression or death from any cause.
Time frame: up to 2 years
Phase II: Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause
Time frame: up to 2 years
Phase II: Disease-free survival (DFS)
From the date of achieving a complete response until disease progression or death from any cause.
Time frame: up to 2 years
Phase II: Event-free survival (EFS)
From the date of the first dose of therapy is given until disease progression, death , or the initiation of a new treatment regimen.
Time frame: up to 2 years
Phase II: The incidence rates of adverse events (AEs)
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Time frame: up to 2 years