Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Relapse
研究概览
简要总结
This phase II trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. After treatment, stem cells are collected from the patient's blood and stored. Higher dose chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant.
SECONDARY OBJECTIVES:
I. Estimate the probability of transplant-related mortality (TRM) at 100 days following autologous stem cell transplant (ASCT).
II. Estimate probabilities of overall and disease-free survival. III. Assess if biological and molecular correlative studies can predict better outcome.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML favorable or intermediate ELN risk
- •Achieved true 1st complete response (CR) (absolute neutrophil count [ANC] and platelet count > 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (MRD)
- •No measurable residual disease (MRD) as assessed by flow cytometry after initial induction therapy
- •Performance score Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
- •Creatinine < 2.0 mg/dl and calculated by Cockcroft-Gault (CG) formula or 24 hour measured creatinine clearance (CRCL) > 50
- •Not pregnant
- •Received 1-2 courses of post remission "consolidation" therapy prior to mobilization PBSC
- •No MRD by flow, cytogenetics, fluorescence in situ hybridization (FISH) and molecular testing prior to collection of autologous PBSC collection
- •Plan is to collect at least 3 x 10^6 CD34+ PBSC/kg cryopreserved; preference is 4-5 X 10^6 CD34 cells/kg
排除标准
- •Life expectancy is severely limited by diseases other than AML
- •Total bilirubin > 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal (ULN)
- •History of Gilbert's disease
- •Uncontrolled arrhythmias, left ventricular ejection fraction (LVEF) < 50% or corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 50%
- •Significant active infection that precludes transplant
- •Hepatitis B or C viremia at time of ASCT
- •History of central nervous system (CNS) involvement with AML
研究组 & 干预措施
Treatment (busulfan, etoposide, ASCT)
Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Treatment (busulfan, etoposide, ASCT)
Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
干预措施: Busulfan (Drug)
Treatment (busulfan, etoposide, ASCT)
Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
干预措施: Etoposide (Drug)
Treatment (busulfan, etoposide, ASCT)
Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Relapse
时间窗: Assessed up to 2 years post autologous stem cell transplant (ASCT)
Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.
Treatment related mortality
时间窗: From first dose of study therapy to day +100
Number of deaths without a prior relapse (unrelated to disease)
次要结局
- Disease-free survival(Assessed up to 4 years post-ASCT)
- Overall survival(Assessed up to 4 years post-ASCT)