Status:
ACTIVE_NOT_RECRUITING
GVM±R in Patients With Relapsed or Refractory Aggressive NHL
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Non Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a prospective, dose-escalation 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, single-center, dose-escalation clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with gemcitabine, vinorelbine and/...
Eligibility Criteria
Inclusion
- Subjects fully understand and voluntarily participate in this study and sign the informed consent
- Age ≥18, ≤70years, no gender limitation
- Expected survival ≥ 3 months;
- Histologically confirmed diagnosis of aggressive NHL.
- Subjects with relapsed or refractory NHL. Relapsed disease is defined as the disease relapsing after CR or PR, and the duration of prior response is more than 6 months. Refractory disease can be confirmed if any of the following conditions are met: 1) no PR or CR has been obtained after previous treatment; 2) CR / PR was achieved after prior therapy, but recurred within 6 months; 3) Recurrence after hematopoietic stem cell transplantation.
- Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be \> 1.5cm; For non-lymph node lesions, the length and diameter should be \> 1.0cm;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) : 0-1
- The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/ L, Hemoglobin(HB)≥ 80g/L, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Serum creatinine (Scr) ≤1.5X 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 (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 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 of the first administration of study drugs;
- 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;
- Cardiac ejection fraction (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.
- 9\. Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x103 copy/mL; hepatitis C virus RNA high than 1x103 copy/mL) 10. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive) 11. 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. 12. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 13. Unsuitable subjects for this study determined by the investigator.
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05299164
Start Date
May 15 2022
End Date
December 31 2025
Last Update
May 13 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
Tianjin, Please Select, China, 300020