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

NCT ID: NCT06244368

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2027-12-30

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).

Detailed Description

This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with gemcitabine, vinorelbine and/or anti-CD20 monoclonal antibody(GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with gemcitabine, vinorelbine and/or rituximab (Pts with CD20-positive lymphomas are evaluated by the investigator on whether to combine rituximab or choose another CD20 monoclonal antibody).Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.

Conditions

Peripheral T Cell Lymphoma; Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GVM±R

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

Group Type: EXPERIMENTAL

GVM±R regimen

Intervention Type: 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.

Interventions

GVM±R regimen

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18, ≤65 years.

2. Expected survival ≥ 3 months.

3. 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.

4. 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;

5. Eastern Cooperative Oncology Group (ECOG) : 0-2

6. 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).

7. 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.-

Exclusion Criteria

1. The subject had previously received any of the following anti-tumor treatments:

1. Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;

2. 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);

3. 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;

4. Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days before the first administration of study drugs;

5. Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.

2. Hypersensitivity to any study drug or its components.

3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)

4. Heart function and disease meet one of the following conditions:

1. Long QTc syndrome or QTc interval > 480 ms;

2. Complete left bundle branch block, grade II or III atrioventricular block;

3. Serious and uncontrolled arrhythmias requiring drug treatment;

4. New York Heart Association grade ≥ III;

5. Left Ventricular Ejection Fractions (LVEF)< 50%;

6. 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.

5. Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper limit of normal).

6. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).

7. Patients with other malignant tumors, except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years.

8. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.

9. ≥ Grade 3 neuritis.

10. Active central nervous system (CNS) lymphoma;

11. Unsuitable subjects for this study determined by the investigator. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

Chengdu Shangjin Nanfu Hospital

UNKNOWN

Sponsor Role: collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

The Affiliated Ganzhou Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

People's Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Liu

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Xiaojing Yan

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

HaiSheng、Chen Liu 、Huang

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Yongqian Jia

Role: PRINCIPAL_INVESTIGATOR

Chengdu Shangjin Nanfu Hospital

Yunhong Huang

Role: PRINCIPAL_INVESTIGATOR

Affiliated Cancer Hospital & Institute of Guizhou Medical University

Xiaobo Wang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Dalian Medical University

Wanling Sun

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Mingxing Zhong

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Ganzhou Hospital of Nanchang University

Liang Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Xiuli Sun

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Ou Bai

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Shuxia Guo

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Zhengzhou University

Yanli Yang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Bengbu Medical University

Zeping Zhou

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Kunming Medical University

Fei Li

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Aichun Liu

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Aijun Liao

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Hongmei Jing

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Shuye Wang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Zhenling Li

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Liu

Role: CONTACT

liuwei@ihcams.ac.cn

022-23608461

Facility Contacts

Wei Liu

Role: primary

liuwei@ihcams.ac.cn

Role: backup

liuwei@ihcams.ac.cn

Other Identifiers

IIT2023065

Identifier Type: -

Identifier Source: org_study_id