A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome, Gemcitabine, Vinorelbine With or Without Anti-CD20 Monoclonal Antibody (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.-

Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
RECRUITING
Tianjin
Contact Information
Primary
Wei Liu
liuwei@ihcams.ac.cn
022-23608461
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 115
Treatments
Experimental: GVM±R
Patients with relapsed or refractory aggressive NHL will undergo GVM±R therapy
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, The First Affiliated Hospital of Nanchang University, The Affiliated Ganzhou Hospital of Nanchang University, Xuanwu Hospital, Beijing, The First Affiliated Hospital of Bengbu Medical University, The First Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, First Hospital of China Medical University, Chengdu Shangjin Nanfu Hospital, Shengjing Hospital, China-Japan Friendship Hospital, People's Hospital of Zhengzhou University, The Second Affiliated Hospital of Kunming Medical University, Peking University Third Hospital, Beijing Tongren Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov