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GVM±R in Patients With Relapsed or Refractory Aggressive NHL
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
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).
Official title: Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-05-15
Completion Date
2025-12-31
Last Updated
2025-05-13
Healthy Volunteers
No
Conditions
Interventions
Liposomal Mitoxantrone Hydrochloride dose level 1
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 dose level 2
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;
Liposomal Mitoxantrone Hydrochloride dose level 3
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 dose level 4
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;
Locations (1)
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Tianjin, Please Select, China