This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma
This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (12 mg/m2,16 mg/m2, 20 mg/m2) and be combined with gemcitabine, dexamethasone, and cisplatin. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxantrone hydrochloride liposome at RP2D dose level combined with gemcitabine, dexamethasone, and cisplatin was conducted to explore the efficacy and safety tolerance of the combined regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: gemcitabine (1000 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. Drug: dexamethasone (40 mg) will be administered on day 1-4 of each 21-day cycle. Drug: cisplatin (75 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
Beijing Hospital
Beijing, China
NOT_YET_RECRUITINGBeijing Luhe Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGChina-Japan Friendship Hospital
Beijing, China
NOT_YET_RECRUITINGRecommended Phase II Dose(RP2D)
To identify the RP2D
Time frame: 1 year
Objective response rate (ORR)
The ORR was defined as the proportion of patients who achieved CR or PR
Time frame: 3 year
Dose limited toxicities (DLTs)
Time frame: 1 year
maximum-tolerated dose(MTD)
Time frame: 1 year
The incidence of AE and SAE
Time frame: 3 year
Complete response rate (CRR)
Time frame: 3 year
Duration of Response(DOR)
Time frame: 3 year
progression-free survival(PFS)
Time frame: 3 year
Overall survival(OS)
Time frame: 3 year
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Peking Union Medical College Hospital
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
NOT_YET_RECRUITING