This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.
This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma.Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, etoposide and prednisone.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
115
Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks;
Tianjin Cancer Hospital
Tianjin, China
RECRUITINGComplete Response Rate (CRR)
Response is assessed according to the lugano criteria.
Time frame: 2 year
Overall Response Rate (ORR)
Response is assessed according to the lugano criteria.
Time frame: 2 year
Progression-Free-Survival (PFS)
From the date of the first dose of therapy is given until disease progression, death or last follow-up.
Time frame: 2 year
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Time frame: 2 year
Safety and Tolerability
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
Time frame: From the first day of medication to 28 days after the last dose
Changes in cardiac safety indicators
such as LVEF% change from baseline, cardiac injury indicators, etc.
Time frame: 2 year
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