Trial Search Results

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

The purpose of this study is to see if we can improve the remission and survival rates for children with AML/MDS and the ways that fungal infections are diagnosed in patients withAML/MDS. We also will study the effects of clofarabine, sorafenib and valproic acid in high risk patients and how leukemia cells react to chemotherapy during treatment.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborator: Genzyme, a Sanofi Company

Stanford Investigator(s):


  • Drug: Cytarabine
  • Drug: Daunorubicin
  • Drug: Etoposide
  • Drug: Clofarabine
  • Device: CliniMACS


Phase 3


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.

Ages Eligible for Study

N/A - 21 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting