Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06244368

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-05-14

115

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

I

Institute of Hematology & Blood Diseases Hospital, China

Lead Sponsor

F

First Hospital of China Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

CONDITIONS

Official Title

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Expected survival of at least 3 months
  • Diagnosed with aggressive NHL that is relapsed or refractory after at least one standard therapy or achieved partial response after at least 4 therapy cycles
  • At least one measurable lesion according to Lugano 2014 criteria (lymph node >1.5 cm; non-lymph node >1.0 cm)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate blood counts: ANC ≥1.5x10⁹/L, platelets ≥75x10⁹/L, hemoglobin ≥80 g/L (with relaxed limits if bone marrow involved)
  • Adequate liver and kidney function within specified limits
Not Eligible

You will not qualify if you...

  • Prior treatment with mitoxantrone or mitoxantrone liposomes
  • Prior doxorubicin or anthracycline treatment exceeding cumulative doses (doxorubicin >360 mg/m² or equivalent)
  • Anti-tumor treatment or participation in other clinical trials within 4 weeks or 5 half-lives before study drug administration
  • Autologous or allogeneic hematopoietic stem cell transplantation within 100 days before study drug administration
  • Previous chimeric antigen receptor T-cell (CAR-T) therapy
  • Hypersensitivity to study drugs or components
  • Uncontrolled systemic diseases such as active infection, uncontrolled hypertension, or diabetes
  • Significant heart conditions including long QTc, severe arrhythmias, heart failure NYHA grade ≥ III, or recent serious cardiac events
  • Active hepatitis B or C infection
  • HIV infection
  • Other malignant tumors except controlled non-melanoma skin basal cell carcinoma or certain carcinoma in situ without treatment in past 5 years
  • Pregnant or lactating women and those unwilling to use contraception
  • Grade 3 or higher neuritis
  • Active central nervous system lymphoma
  • Any other conditions making the subject unsuitable for the study as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

W

Wei Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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