AC220 for Children With Relapsed/Refractory ALL or AML
Condition: Lymphoblastic Leukemia, Acute, Childhood; Myelogenous Leukemia, Acute, Childhood
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study of the investigational drug AC220 combined with cytarabine and
      etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute
      myelogenous leukemia (AML).
    

Detailed description: 
      This is a study for pediatric patients with relapsed acute lymphoblastic leukemia (ALL) or
      acute myelogenous leukemia (AML). Some people diagnosed with leukemia have changes in a
      receptor located on the surface of white blood cells called FLT3. This is known as a FLT3
      mutation. FLT3 plays an important role in the way cells grow and divide. In normal cells, the
      FLT3 receptor is switched off most of the time and only switches on when it gets a chemical
      signal from outside. But cells with the FLT3 mutation have the grow signal permanently
      switched on. This means leukemia cells with the FLT3 mutation are growing and dividing all
      the time. Doctors have found that people with leukemia cells that carry FLT3 mutations are
      less likely to go into remission with chemotherapy and have a higher risk of the leukemia
      coming back after treatment.

      This is a study of an investigational drug called AC220. AC220 is considered investigational
      because it has not been approved in the United States by the Food and Drug Administration
      (FDA). AC220 is a drug which is able to "turn off" the FLT3 grow signal. AC220 will be given
      with cytarabine and etoposide to treat the relapsed leukemia. This is a phase I study, which
      means that the study is being done to find the highest dose of AC220 that can be given safely
      with the drugs cytarabine and etoposide to children and young adults.
    

Intervention name(s): AC220; Cytarabine; Etoposide; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose assigned at study entry. AC220 will be given orally once daily on days 7-28.; All patients receive 1000 mg/m2/day IV given every 12 hours on days 1 through 5. Additionally, AML patients and patients with ambiguous leukemia receive cytarabine intrathecally on day "1" of course 1 and 2. Dose defined by age:
20 mg for patients age <1 yr
30 mg for patients age 1-1.99 years of age
50 mg for patients age 2-2.99 years of age
70 mg for patients >3 years of age; 150 mg/m2/day IV on days 1 through 5.; IT methotrexate given intrathecally to patients with ALL on day "0" of course 1 and 2. Dose defined by age
6 mg for patients age < 1yr
8 mg for patients age 1-1.99
10 mg for patients age 2-2.99
12 mg for patients 3-8.99 years of age
15 mg for patients >9 years of age
Other intervention name(s): Quizartinib; Cytosine Arabinoside; Ara-C; Cytosar®-U; Arabinosylcytosine; VePesid®; Etopophos; VP-16; Toposar®; Etoposide phosphate; MTX; Amethopterin; Otrexup™; Rasuvo®; Rheumatrex®; Trexall™; Methotrexate Sodium
Intervention MeSH terms: Cytarabine; Methotrexate; Etoposide; Etoposide phosphate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; Lymphoblastic; Leukemia; AC220; Refractory; Myelogenous; Acute; Childhood; Pediatric; ALL; AML