Last updated on February 2018

Study to Improve OS in 18 to 60 Year-old Patients Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia
  • Age: Between 18 - 61 Years
  • Gender: Male or Female

Inclusion Criteria (at diagnosis) :

  1. Age 18 years and < 61 years
  2. With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
  3. No prior treatment for AML, with the exception of hydroxyurea
  4. ECOG performance status 3
  5. No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) < 50%
  6. Total bilirubin 2 x upper limit of normal (UNL), ASAT(SGOT) and ALAT (SGPT) 2.5 X UNL, creatinine < 150 mol/l, unless AML-related out of range values
  7. Women of childbearing potential should use appropriate methods of contraception
  8. Health insurance coverage
  9. Signed informed consent

Exclusion criteria (at diagnosis) :

  1. Patients with acute promyelocytic leukemia (APL), as confirmed either by t(15;17) or by the presence of PML-RARA fusion transcripts
  2. Patients with core binding factor (CBF) AML, as confirmed either by t(8;21), t(16,16) or inv(16), or by fusion transcripts resulting from these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11).
  3. Patients with secondary AML arising from myeloproliferative disorders previously known according to the 2008 WHO classification
  4. Patients with Ph1+ AML or previous Ph1+ disorder (chronic myelogenous leukemia)
  5. Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment, including allogeneic HSCT
  6. No psychological, familial, social, or geographic reason that would compromise clinical follow up
  7. History of uncontrolled cancer for the last 2 years, with the exception of basal cell carcinoma or carcinoma in situ of the cervix
  8. Uncontrolled severe infection
  9. Patients with positive serology for HIV-1 and -2, or HTLV -1 and -2, or active hepatitis virus B or C infection
  10. Pregnant or lactating women
  11. Legal incapacity (patients under tutorship, curatorship or judicial protection)

For randomization R4-VOS (post-induction/salvage):

Inclusion criteria

  1. Patients enrolled in the BIG-1 trial at diagnosis
  2. Patients achieving first CR/CRp/CRi after induction or salvage therapy (within 15 days before R4-VOS)
  3. Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification
  4. Patients randomized to R2-IDAC arm (intermediate dose cytarabine)
  5. ECOG performance status 2
  6. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
  7. Local clinical laboratory values as follows:
    • Serum creatinine 2.0 mg/dL
    • Total bilirubin 1.5 X the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) 2.5 X ULN
    • Alanine aminotransferase (ALT) 2.5 X ULN
  8. Signed written informed consent for vosaroxin study (R4-VOS)
  9. Women of childbearing potential must have a negative pregnancy test within 8 days before randomization R4-VOS and commit to the use of effective contraception during the period of treatment and up to 36 days after vosaroxin has been stopped. Men must use effective contraception during the treatment period and up to 96 days after vosaroxin has been stopped.

Exclusion criteria

  1. Severe uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever
  2. Documented uncontrolled fungal infection (positive blood test and cultures)
  3. History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization
  4. Patient under hemodialysis (HD) or peritoneal dialysis (PD)

For randomization R3 (before AlloHSCT):

Inclusion criteria

  1. Patients enrolled in the BIG-1 trial at diagnosis
  2. Patients achieving first CR after induction or salvage therapy
  3. Patients belonging to the intermediate AML risk group as defined in the protocol BIG-1
  4. Signed informed consent for R3

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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