This is a prospective, dose-escalation clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).
This is a single-arm, single-center, dose-escalation clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, vinorelbine and/or rituximab (GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). Liposomal mitoxantrone hydrochloride will be given on day 1 at four different doses (16 mg/m2, 18 mg/m2, 20 mg/m2,22 mg/m2) and be combined with gemcitabine, vinorelbine and/or rituximab (rituximab only in CD20+ lymphoma). 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Liposomal Mitoxantrone Hydrochloride 16 mg/m\^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m\^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m\^2) on day 1,8, every 3 weeks; Rituximab (375mg/m\^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Liposomal Mitoxantrone Hydrochloride 18 mg/m\^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m\^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m\^2) on day 1,8, every 3 weeks; Rituximab (375mg/m\^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Tianjin, Please Select, China
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in GVM±R
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
Dose limited toxicities (DLTs)
adverse events (AE) defined as DLT events per protocol
Time frame: Through the last patient complete his DLT observation, assessed up to 21 days
The incidence rates 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 2 years
Complete response rate (CRR)
Response is assessed according to the lugano criteria
Time frame: : up to 2 years
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: up to 2 years
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Liposomal Mitoxantrone Hydrochloride 20 mg/m\^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m\^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m\^2) on day 1,8, every 3 weeks; Rituximab (375mg/m\^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;
Liposomal Mitoxantrone Hydrochloride 22 mg/m\^2 (with a caret included) on day 1, every 3 weeks; Gemcitabine (800 mg/m\^2) on day 1,8, every 3 weeks; Vinorelbine (25mg/m\^2) on day 1,8, every 3 weeks; Rituximab (375mg/m\^2) on day 1, every 3 weeks, only used in patients with CD20+ lymphoma;