Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- rates of complete remission
研究概览
简要总结
The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.
详细描述
This will be a pilot study that will include patients with AML receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). All patients will have a planned mid-induction bone marrow assessment as standard of care. All patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. Patients with complete remission (CR) will proceed to consolidation chemotherapy as determined by the treating investigator. Patients with refractory disease will proceed to further therapy as determined by the treating investigator. All patients will be followed for long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female, age ≥18
- •Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
- •Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
- •Cardiac function: Ejection fraction >50-55%
- •Adequate organ function for receipt for induction chemotherapy
- •Patients with HIV and Hepatitis B or C should have controlled disease.
- •Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.
排除标准
- •Any other active malignancy requiring treatment or with expected survival ≤1 year.
- •Recipients of prior allogeneic stem cell transplant.
- •Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
- •Patients with active CNS disease
- •Patients with APL
- •Received any investigational drugs within the 14 days prior to the first day of induction
- •Pregnant and/or breastfeeding
结局指标
主要结局
rates of complete remission
时间窗: 28 days
rates of complete remission in consecutive patients with AML, receiving standard induction chemotherapy, without intervening on the results of the mid-induction bone marrow biopsy.
次要结局
未报告次要终点
研究者
Omer Jamy
Associate Professor
University of Alabama at Birmingham