Phase
Condition
Lymphoma
Hematologic Cancer
Non-hodgkin's Lymphoma
Treatment
GVM±R regimen
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18, ≤65 years.
Expected survival ≥ 3 months.
Subjects with aggressive NHL who have relapsed or proven refractory to at least oneline 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-provenresidual disease). Relapse is defined as a disease response (PR/CR) to the last-linetherapy with a duration of response exceeding 6 months. Refractory disease can beconfirmed under any of the following conditions: 1) no partial or complete responseto the last-line therapy; 2) the duration of complete or partial response to thelast-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 lymphnode lesions, the long diameter should be > 1.5cm; For non-lymph node lesions, thelong 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 bonemarrow 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 involvesthe liver, TBIL≤3 X ULN.AST and ALT≤5 X ULN). For Pts diagnosed with Gilbert'sdisease, TBIL was enrolled if it was ≤3 X ULN.-
Exclusion
Exclusion Criteria:
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 totalcumulative dose of doxorubicin was more than 360 mg/m2 (For otheranthracyclines, 1 mg doxorubicin equivalent to 2 mg epirubicin);
Subjects who received anti-tumor treatment (including chemotherapy, targetedtherapy, 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 administrationof the study drugs;
Subjects who received autologous hematopoietic stem cell transplantation orallogeneic hematopoietic stem cell transplantation within 100 days before thefirst 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 unstableventricular arrhythmia or any other arrhythmia requiring treatment, a historyof clinically serious pericardial disease, or ECG evidence of acute ischemia oractive conduction system abnormalities within 6 months before recruitment.
Active hepatitis B and C infection (defined as hepatitis B virus surface antigenpositive 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 Upperlimit of normal).
Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).
Patients with other malignant tumors, except for effectively controlled non-melanomaskin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors withouttreatment during the past 5 years.
Pregnant and lactating women and patients of childbearing age who are unwilling totake contraceptive measures.
≥ Grade 3 neuritis.
Active central nervous system (CNS) lymphoma;
Unsuitable subjects for this study determined by the investigator. -
Study Design
Study Description
Connect with a study center
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Tianjin, Tianjin 300020
ChinaActive - Recruiting
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