Trial Search Results

A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia

The purpose of this study is to compare the good and bad effects of giving either azacitidine OR decitabine before the usual chemotherapy regimen for childhood AML. The DNA MethylTransferase inhibitor (DMTi) drugs, azacitidine and decitabine are both approved by the Food and Drug Administration (FDA) for treating adults with myelodysplastic syndrome.These drugs are not FDA approved for treating children with leukemia. This study will allow the researchers to know if adding either azacitidine or decitabine will be better, the same, or worse when added to standard chemotherapy for AML. Researchers also want to know if azacitidine or decitabine will be safe, and if one of the drugs will be betterthan the other.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

St. Jude Children's Research Hospital

Stanford Investigator(s):

Intervention(s):

  • Drug: Azacitidine
  • Drug: Decitabine
  • Drug: Cytarabine
  • Drug: Daunorubicin
  • Drug: Etoposide
  • Combination Product: ITMHA
  • Drug: Idarubicin
  • Drug: Fludarabine
  • Drug: Mitoxantrone
  • Drug: Erwinia asparaginase
  • Drug: Sorafenib
  • Drug: G-CSF
  • Drug: Dexrazoxane
  • Biological: Stem Cell Transplant

Phase:

Phase 2

Eligibility


INCLUSION CRITERIA:

   - Diagnostic criteria: Patients must have one of the following diagnoses:

      - Acute myeloid leukemia fulfilling the criteria of the WHO Classification (see
      Appendix I), or

      - >5% but < 20% marrow myeloblasts and evidence of a clonal de novo AML genetic
      abnormality [e.g., t(8;21), inv(16), t(9;11)], or

      - Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic
      sarcoma, or chloroma), with or without evidence of a leukemia process in the bone
      marrow or peripheral blood, with confirmation of myeloid differentiation, or

      - High grade myelodysplastic syndrome (MDS) with greater than 5% blasts, or

      - Patients with treatment related myeloid neoplasms including AML and MDS, provided
      their cumulative anthracycline dose has not exceeded 230 mg/m2 doxorubicin
      equivalents.

   - Other criteria - Patients must meet all the following criteria:

      - Age > 28 days and < 22 years at time of study entry inclusive, and

      - 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), and

      - Written informed consent according to institutional guidelines, and

      - Female patients of childbearing potential must have a negative pregnancy test
      within 2 weeks prior to enrollment, and

      - Male and female participants of reproductive potential 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)

   - BCR-ABL1 chronic myeloid leukemia in blast crisis (CML-BC)

   - Juvenile myelomonocytic leukemia (JMML)

   - Fanconi anemia (FA)

   - Kostmann syndrome

   - Shwachman syndrome

   - Other bone marrow failure syndromes or low grade (<5% bone marrow blasts) MDS.

   - 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 for this
   malignancy within 2 weeks before study entry with the exception of IT therapy,
   hydroxyurea, or low-dose cytarabine as specified in the protocol document. 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.

   - 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.

   - Prior chemotherapy, with the exception of hydroxyurea or low-dose cytarabine as
   specified in the protocol document. The patient must have recovered from all acute
   toxicities from any previous therapy.

   - Patients with treatment related myeloid neoplasms with cumulative anthracyclines
   greater than 230 mg/m2 doxorubicin equivalents.

Ages Eligible for Study

N/A - 21 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christopher Le
650-725-4318
Recruiting