NCT03324243撤回2 期
A Phase II Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of patients experiencing ≥ Grade 3 adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is a phase II, multicenter, single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsed/refractory FLT3-mutated AML. Patients will receive up to two courses of salvage chemotherapy with fludarabine, cytarabine, and crenolanib. Response will be assessed between day 29-43 of each course.
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
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 1 years and ≤ 21 years
- •Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
- •Definitive evidence of a FLT3-ITD and/or FLT3-TKD (D835/I836) mutation at the time of enrollment
- •Patients must have histologically or molecularly confirmed relapsed or refractory AML
- •Karnofsky or Lansky performance score ≥
- •Use Karnofsky for patients > 16 years old and Lansky for patients ≤ 16 years of age.
- •Adequate renal function, defined as:
- •Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or
- •Normal serum creatinine based on age/gender
- •Adequate liver function, defined as:
- •Serum total bilirubin ≤ 1.5x ULN for age,
- •Serum aspartate aminotransferase (AST) ≤ 3.0x ULN for age, and
- •Serum alanine aminotransferase (ALT) ≤ 3.0x ULN for age.
排除标准
- •Patients with any of the following current or previous diagnoses:
- •Acute promyelocytic leukemia (APL)
- •Down syndrome
- •DNA fragility or bone marrow failure syndromes (such as Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Shwachman syndrome)
- •AML secondary to prior MDS/MPN, including chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia
- •Blastic plasmacytoid dendritic cell neoplasm
- •Acute leukemia of ambiguous lineage
- •B-lymphoblastic leukemia/lymphoma
- •T-lymphoblastic leukemia/lymphoma, including early T-cell precursor lymphoblastic leukemia (ETP-ALL)
- •Patients who are refractory to first line (induction and re-induction) and a second line (1st salvage) treatment for AML.
- •Patients who have received more than 1 prior allogeneic HSCT
- •Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection of which they exhibit ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
- •Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
- •Known severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia)
- •Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •Currently receiving prophylactic treatment of hepatitis B with anti-viral therapy
- •Known infection with human immunodeficiency virus (HIV)
研究组 & 干预措施
Crenolanib
Experimental
干预措施: Crenolanib (Drug)
Crenolanib
Experimental
干预措施: Fludarabine (Drug)
Crenolanib
Experimental
干预措施: Cytarabine (Drug)
结局指标
主要结局
Number of patients experiencing ≥ Grade 3 adverse events as assessed by CTCAE v4.0
时间窗: From study entry to 30 days post-treatment
Number of patients experiencing Grade 4 adverse events related to crenolanib as assessed by CTCAE v4.0
时间窗: 60 days
Rate of early mortality
时间窗: 60 days
Number of patients who died within 60 days of start of therapy
次要结局
- Event-free survival (EFS)(4 years)
- Relapse-free survival (RFS)(4 years)
- Overall survival (OS)(4 years)
研究者
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