NCT00070174已完成2 期
Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 148
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy.
- Determine the complete remission rate of patients treated with this regimen.
Secondary
- Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients.
- Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed primary acute myeloid leukemia (AML)
- •At least 20% bone marrow blasts
- •Meets the customary FAB criteria for AML
- •Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts
- •Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above
- •Previously untreated disease
- •No promyelocytic leukemia (FAB M3)
- •No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)
- •No juvenile myelomonocytic leukemia
- •No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
- •No Down syndrome
- •PATIENT CHARACTERISTICS:
- •1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed
- •Performance status
- •Karnofsky 50-100% (over 16 years of age) OR
- •Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •No inadequate liver function
- •No inadequate renal function
- •No hyperuricemia (greater than 8.0 mg/dL)
- •Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR
- •Creatinine no greater than 1.5 times normal
- •Cardiovascular
- •Shortening fraction at least 27% by echocardiogram OR
- •Ejection fraction at least 50% by MUGA
- •No proven or suspected pneumonia
- •Not pregnant or nursing
- •No proven or suspected sepsis or meningitis
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis
- •Endocrine therapy
- •Prior topical and inhalation steroids allowed
- •No concurrent steroids as antiemetics
- •Radiotherapy
- •No prior radiotherapy
- •Not specified
- •No prior antileukemic therapy
- •No concurrent pressor agent or ventilatory support unless approved by the study chair
- •No concurrent participation in another COG therapeutic study
排除标准
- 未提供
结局指标
主要结局
Safety
Complete remission rate
次要结局
- Feasibility
- Effect of karyotypic abnormalities
研究者
研究点 (148)
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