A Prospective, Multicenter Clinical Study of Pomalidomide Combined With Orelabrutinib and Zuberitamab in Treatment-Naive Mantle Cell Lymphoma
概览
- 阶段
- 不适用
- 干预措施
- Pomalidomide
- 疾病 / 适应症
- 未指定
- 发起方
- Peking University Third Hospital
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Minimum residual disease (MRD) rate
- 状态
- 招募中
- 最后更新
- 5个月前
概览
简要总结
This multicenter trial evaluates the efficacy and safety of pomalidomide combined with orelabrutinib and zuberitamab (POZ) in patients with mantle cell lymphoma (MCL). After six cycles of POZ, patients who achieved minimal residual disease (MRD) negativity received maintenance therapy with orelabrutinib plus zuberitamab for up to 18 cycles. Those with MRD positivity were excluded and received alternative treatments. The primary endpoint is the MRD rate after six cycles of POZ. Secondary endpoints include progression-free survival (PFS), overall survival (OS), MRD rate, objective response rate (ORR), and safety.
研究者
入排标准
入选标准
- •Pathologically confirmed mantle cell lymphoma
- •Age 18-80 years, both genders are eligible..
- •Untreated MCL.
- •At least one measurable lesion. Measurable disease is defined as a tumor mass measurable in one or two dimensions ≥1.5 cm, as well as measurable spleen lesions.
- •Any one of the following factors is present:: MIPI intermediate-high risk, ki67≥30%, blastoid/pleomorphic, TP53 abnormality (mutation/deletion) or p53 protein expression \>50%, large mass (maximum diameter ≥7.5cm), complex karyotype (≥3 chromosomal abnormalities (excluding t(11; 14)))
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Hematologic function is adequate, defined as:
- •Absolute neutrophil count (ANC) ≥1×109/L, growth factor support must not be used within 7 days prior to testing;
- •Platelet count ≥75×10⁹/L, or ≥50×10⁹/L (if bone marrow involvement), no use of growth factor support or transfusion allowed within 7 days prior to testing.
- •Adequate hepatic function per local laboratory reference range as follow:
排除标准
- •Current central nervous system involvement or suspected patients and those with a history of this condition
- •Previously received systemic treatment for MCL, including BTKi.
- •Uncontrolled active systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to the infection despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments with no improvement).
- •Known human immunodeficiency virus (HIV) infection, or the following serological status indicating active hepatitis B or C virus infection:
- •Subjects with positive hepatitis B virus core antibody (HBcAb) and negative surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result prior to the first dose. Subjects with positive HBsAg or HBV-DNA:
- •Subjects with positive hepatitis C antibodies must have an HCV-RNA negative result before the first dose. Subjects with positive hepatitis C PCR results will not be eligible for this study.
- •Clinically severe cardiovascular diseases, including:
- •Myocardial infarction occurring within the 6 months prior to screening;
- •Unstable angina occurring within 3 months prior to screening;
- •Clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia);
研究组 & 干预措施
Pomalidomide + Orelabrutinib + Zuberitamab and Orelabrutinib + Zuberitamab Maintenance
1\. In induction phase, patients will receive pomalidomide 4mg/day PO once daily day1-12/cycle; orelabrutinib 150 mg/day PO once daily; and zuberitamab 375 mg/m² IV on day 1/cycle, every 28 day per cycle for 6 cycles. 2. In maintenance phase, Patients with MRD negative (≤10-5) after induction therapy will recieve orelabrutinib 150 mg/day PO once daily for 18cycles and zuberitamab 375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22, every 28 day per cycle.
干预措施: Pomalidomide
Pomalidomide + Orelabrutinib + Zuberitamab and Orelabrutinib + Zuberitamab Maintenance
1\. In induction phase, patients will receive pomalidomide 4mg/day PO once daily day1-12/cycle; orelabrutinib 150 mg/day PO once daily; and zuberitamab 375 mg/m² IV on day 1/cycle, every 28 day per cycle for 6 cycles. 2. In maintenance phase, Patients with MRD negative (≤10-5) after induction therapy will recieve orelabrutinib 150 mg/day PO once daily for 18cycles and zuberitamab 375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22, every 28 day per cycle.
干预措施: Orelabrutinib
Pomalidomide + Orelabrutinib + Zuberitamab and Orelabrutinib + Zuberitamab Maintenance
1\. In induction phase, patients will receive pomalidomide 4mg/day PO once daily day1-12/cycle; orelabrutinib 150 mg/day PO once daily; and zuberitamab 375 mg/m² IV on day 1/cycle, every 28 day per cycle for 6 cycles. 2. In maintenance phase, Patients with MRD negative (≤10-5) after induction therapy will recieve orelabrutinib 150 mg/day PO once daily for 18cycles and zuberitamab 375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22, every 28 day per cycle.
干预措施: Zuberitamab
结局指标
主要结局
Minimum residual disease (MRD) rate
时间窗: 6 months
After 6 cycles of the pomalidomide combined with orelabrutinib and zuberitamab (POZ) regimen, the proportion of patients with undetectable minimal residual disease (MRD) (≤10-5) as evaluated by the high-throughput sequencing (NGS) platform.
次要结局
- MRD rate(24 months)
- Overall Response Rate(up to 3 years)
- Progression-free survival(up to 3 years)
- Overall survival(up to 3 years)