Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

Not Recruiting

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.

Official Title

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

Stanford Investigator(s)


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.


drug: Cytarabine

drug: Daunorubicin

drug: Etoposide

drug: Clofarabine

device: CliniMACS

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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