A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers a chemotherapy known as calicheamicin to kill them.
详细描述
OUTLINE:
Patients receive gemtuzumab ozogamicin intravenously (IV) on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis AML based on 2016 World Health Organization criteria. Acute promyelocytic leukemia (APL) and biphenotypic AML are not eligible
- •Patients must have MRD-level disease only and otherwise meet criteria for complete response (CR) or complete remission with incomplete hematologic recovery (CRi) per the 2017 European Leukemia Net response criteria (< 5% blasts in the marrow without a requirement for peripheral blood count recovery). MRD must be measurable by multiparameter flow cytometry (MPFC) and/or polymerase chain reaction (PCR)-based molecular markers and/or karyotypic markers (e.g., classical cytogenetics or fluorescence in situ hybridization). MRD status will be centrally confirmed by the UW/FHCRC clinical laboratory in order to standardize response assessment following administration of study therapy.
- •Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study. However, adult patients (>= 18 years of age) are eligible for participation at any time point in treatment (after induction, during or after consolidation, pre-transplant, or post-transplant).
- •Age >= 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- •Patient's AML blasts must have CD33 expression.
- •For adults (>= 18 years of age): Serum creatinine =< 2.0 mg/dL.
- •For adults (>= 18 years of age): Total bilirubin =< 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease).
- •For adults (>= 18 years of age): Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).
- •Ability of patient to provide written informed consent.
- •Females of childbearing potential must have a negative pregnancy test prior to receiving GO.
- •Patients who re-enroll must have achieved an MRD-negative CR during their prior enrollment
排除标准
- •Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.
- •Subjects may not be receiving other investigational agents.
- •Uncontrolled or concurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Treatment (gemtuzumab ozogamicin)
Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
Treatment (gemtuzumab ozogamicin)
Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.
干预措施: Bone Marrow Aspiration (Procedure)
Treatment (gemtuzumab ozogamicin)
Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Treatment (gemtuzumab ozogamicin)
Patients receive gemtuzumab ozogamicin IV on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. Additionally, patients also undergo bone marrow aspiration and blood sample collection throughout the trial.
干预措施: Gemtuzumab Ozogamicin (Drug)
结局指标
主要结局
Clinical response rate
时间窗: Up to 70 days
Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.
次要结局
- Rate of sinusoidal obstructive syndrome (SOS)(Up to 6 months)
- Rate of allogeneic hematopoietic cell transplantation (HCT)(Up to 6 Months)