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GVM±R in Patients With Relapsed or Refractory Aggressive NHL

NCT05299164 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-13

No results posted yet for this study

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).

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;

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Wei Liu · Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2023-12-18
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299164 on ClinicalTrials.gov