Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Cytarabine; Daunorubicin; Etoposide; Clofarabine; CliniMACS
Intervention description: See Detailed Description; See Detailed Description; See Detailed Description; See Detailed Description; The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Intervention MeSH terms: Cytarabine; Etoposide; Daunorubicin; Clofarabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the feasibility and efficacy of a novel form of
      therapy-haploidentical NK cell transplantation-in patients with standard-risk AML. In
      addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly
      diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted
      therapy and further improvements in supportive care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age less than or equal to 21 years at time of study entry.

          -  No prior therapy for this malignancy except for one dose of intrathecal therapy and
             the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or
             less ) for hyperleukocytosis.

          -  Written informed consent according to institutional guidelines

          -  Female patients of childbearing potential must have a negative serum pregnancy test
             within 2 weeks prior to enrollment

          -  Male and female participants must use an effective contraceptive method during the
             study and for a minimum of 6 months after study treatment.

        Exclusion Criteria:

          -  Down syndrome

          -  Acute Promyelocytic Leukemia (APL)

          -  Juvenile Myelomonocytic Leukemia (JMML)

          -  Fanconi anemia (FA)

          -  Kostmann syndrome

          -  Shwachman syndrome

          -  Other bone marrow failure syndromes

          -  Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as
             specified in the protocol.

          -  Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
             before study entry with the exception of IT therapy, hydroxyurea, or low-dose
             cytarabine as stated above. The patient must have recovered from all acute toxicities
             from any previous therapy.

          -  Systemic fungal, bacterial, viral, or other infection not controlled (defined as
             exhibiting ongoing signs/symptoms related to the infection and without improvement,
             despite appropriate antibiotics or other treatment).

          -  Pregnant or lactating patients.

          -  Any significant concurrent disease, illness, or psychiatric disorder that would
             compromise patient safety or compliance, interfere with consent, study participation,
             follow up, or interpretation of study results.