This is a prospective, single arm, multicenter, dose-escalation clinical study to evaluate the safety and efficacy of CMOEP in patients with untreated Peripheral T-cell Lymphoma.
This is a single arm, multicenter, dose-escalation study which mainly explores the dose limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (15 mg/m2, 18 mg/m2, 20 mg/m2) and be combined with Cyclophosphamide, Vincristine, Etoposide and Prednisone. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Drug: Liposomal mitoxantrone hydrochloride (15 mg/m2, 18 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: Cyclophosphamide (750 mg/ m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: Vincristine (1.4mg/ m2,Max dose 2mg) will be administered by an intravenous injection on day 1of each 21-day cycle. Drug: Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3 of each 21-day cycle. Drug: Prednisone (100 mg) will be taken orally from day 1-5 of each 21-day cycle.
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in CMOEP
Time frame: Cycle 1 (21 days)
Dose limited toxicities (DLTs)
Adverse events (AE) defined as DLT events per protocol
Time frame: Cycle 1 (21 days)
The incidence of AE and SAE
AE or severe adverse events (SAE) occur since the first dose of therapy is given
Time frame: Up to 28 days after the last patient complete his study therapy
Objective response rate (ORR)
Response is assessed according to the lugano criteria
Time frame: Up to 1 year
Complete response rate (CRR)
Response is assessed according to the lugano criteria
Time frame: Up to 1 year
Progression-free survival(PFS)
From the date of the first dose of therapy is given until disease progression, death
Time frame: Up to 1 year
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