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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called GVM±R for patients with aggressive non-Hodgkin's lymphoma (NHL) who have either not responded to previous treatments or have experienced a relapse. The trial is currently recruiting participants aged 18 to 65 who have been diagnosed with certain types of aggressive NHL and have measurable disease. To be eligible, patients must have survived for at least three months after their last treatment and meet specific health criteria, such as having a sufficient blood cell count and stable liver and kidney functions.

Participants in the trial will receive the GVM±R treatment and will be monitored for its safety and effectiveness. The study aims to find out how well this treatment works and whether it is a good option for patients with difficult-to-treat NHL. It's important for potential participants to know that certain health conditions or previous treatments may prevent them from joining the study. If you or someone you know is interested, discussing eligibility with a healthcare provider can provide more personalized information.

Gender

ALL

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. -