GVM±R in Patients With Relapsed or Refractory Aggressive NHL

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 15, 2022

Primary Completion Date

December 18, 2023

Study Completion Date

December 31, 2025

Conditions
Non Hodgkin Lymphoma
Interventions
DRUG

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;

DRUG

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;

DRUG

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;

DRUG

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;

Trial Locations (1)

300020

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC, Tianjin

Sponsors
All Listed Sponsors
collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER

NCT05299164 - GVM±R in Patients With Relapsed or Refractory Aggressive NHL | Biotech Hunter | Biotech Hunter