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

NCT06244368 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2023065
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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

Peripheral T Cell Lymphoma; Diffuse Large B-cell Lymphoma

Keywords

aggressive non-Hodgkin's lymphoma (NHL); Mitoxantrone hydrochloride liposome; GVM±R

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Response is assessed according to the lugano criteria

  up to 2 years

Secondary Outcomes (4)

• Complete Response Rate (CRR)

  up to 2 years

• Progression-Free-Survival (PFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Incidence of Treatment-Emergent Adverse Events

  up to 2 years

Study Arms (1)

GVM±R

EXPERIMENTAL

Patients with relapsed or refractory aggressive NHL will undergo GVM±R therapy

Drug: GVM±R regimen

Interventions

GVM±R regimen DRUG

Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1； Gemcitabine (800 mg/m\^2) on day 1,8； Vinorelbine (20mg/m\^2) on day 1,8； Rituximab (375mg/m\^2) on day 1; The regimen will be administered every 3 weeks, for a maximum of 6 cycles. The choice of CD20 monoclonal antibody will be determined by the attending physician.

GVM±R

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, ≤65 years.
• Expected survival ≥ 3 months.
• Subjects with aggressive NHL who have relapsed or proven refractory to at least one line of standard therapy or have achieved PR as the best response after a minimum of 4 cycles of therapy (patients with a Deauville score of 4 must have biopsy-proven residual disease). Relapse is defined as a disease response (PR/CR) to the last-line therapy with a duration of response exceeding 6 months. Refractory disease can be confirmed under any of the following conditions: 1) no partial or complete response to the last-line therapy; 2) the duration of complete or partial response to the last-line therapy is no longer than 6 months from the last dose of therapy; 3) Recurrence after hematopoietic stem cell transplantation.
• Subjects must have at least one measurable lesion per lugano2014 criteria: for lymph node lesions, the long diameter should be \> 1.5cm; For non-lymph node lesions, the long diameter should be \> 1.0cm;
• Eastern Cooperative Oncology Group (ECOG) : 0-2
• Peripheral blood: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L.(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×109/L, Platelet count (PLT) ≥50×109/L, Hemoglobin(HB)≥ 75g/L).
• Liver and kidney function: Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN).(If the lymphoma involves the liver, TBIL≤3 X ULN.AST and ALT≤5 X ULN). For Pts diagnosed with Gilbert's disease, TBIL was enrolled if it was ≤3 X ULN.-

You may not qualify if:

• The subject had previously received any of the following anti-tumor treatments:
• Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;
• Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (For other anthracyclines, 1 mg doxorubicin equivalent to 2 mg epirubicin);
• Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks or 5 half-lives((whichever comes first) before the first administration of the study drugs;
• Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days before the first administration of study drugs;
• Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.
• Hypersensitivity to any study drug or its components.
• Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
• Heart function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval \> 480 ms;
• Complete left bundle branch block, grade II or III atrioventricular block;
• Serious and uncontrolled arrhythmias requiring drug treatment;
• New York Heart Association grade ≥ III;
• Left Ventricular Ejection Fractions (LVEF)\< 50%;
• A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• First Hospital of China Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Chengdu Shangjin Nanfu Hospital: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• The Affiliated Ganzhou Hospital of Nanchang University: collaborator
• Beijing Tongren Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• People's Hospital of Zhengzhou University: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Shengjing Hospital: collaborator
• Peking University Third Hospital: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Wei Liu

  Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

  PRINCIPAL INVESTIGATOR

• Xiaojing Yan

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• HaiSheng、Chen Liu 、Huang

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

• Yongqian Jia

  Chengdu Shangjin Nanfu Hospital

  PRINCIPAL INVESTIGATOR

• Yunhong Huang

  Affiliated Cancer Hospital & Institute of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

• Xiaobo Wang

  The Second Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Wanling Sun

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Mingxing Zhong

  The Affiliated Ganzhou Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Liang Wang

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

• Xiuli Sun

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Ou Bai

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Shuxia Guo

  People's Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Yanli Yang

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Zeping Zhou

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

• Fei Li

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Aichun Liu

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Aijun Liao

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

• Hongmei Jing

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Shuye Wang

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Zhenling Li

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu

CONTACT

022-23608461; liuwei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: January 17, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)