Tests a drug combination in adults with returned aggressive lymphoma

Trial details

Who runs it

Institute of Hematology & Blood Diseases Hospital, China

Trial code

NCT06244368

Record updated

14 May 2025

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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.-.

Exclusion: 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.); Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive); 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; 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; 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); Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; ≥ Grade 3 neuritis; Active central nervous system (CNS) lymphoma; Unsuitable subjects for this study determined by the investigator. -.

ClinicalTrials.gov NCT06244368