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Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Trial ID: NCT00703820
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.
AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia
- 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.
- 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.
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