High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML
Condition: ACUTE MYELOGENOUS LEUKEMIA
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      Determine the effects of escalated dose of daunorubicin in induction treatment of adult
      patients with acute myelogenous leukemia who are younger than 60 years of age.
    

Detailed description: 
      1. Induction chemotherapy

             -  For patients randomized to receive regular dose of Daunorubicin (Arm I) will be
                given Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7
                days along with Daunorubicin 45 mg/m2/day by continuous iv infusion over 24 hours
                daily for 3 days.

             -  For patients randomized to receive higher dose of Daunorubicin (Arm II) will be
                given Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7
                days along with Daunorubicin 90 mg/m2/day by continuous iv infusion over 24 hours
                daily for 3 days.

        2. Reinduction chemotherapy

             -  Bone marrow aspiration and biopsy will be performed on day 14 of induction
                chemotherapy. If the bone marrow is hypoplastic and contains no more than 5% blast
                cells, further chemotherapy will be deferred and the marrow examination will be
                repeated at the time of ANC ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral
                blood for the evaluation of complete remission. If more than 5% blast cells persist
                or if the marrow cellularity in the biopsy specimen exceeds 15%, a course of
                reinduction chemotherapy will be given.

             -  Reinduction chemotherapy consists of Cytarabine 200 mg/m2/day by continuous iv
                infusion over 24 hours daily for 5 days along with Daunorubicin 45 mg/m2/day by
                continuous iv infusion over 24 hours daily for 2 days in both arms.

        3. Postremission therapy

             -  The same postremission therapy will be given to the patients in both arms.

             -  Four courses of Cytarabine 3 g/m2 will be administered in a 3-hour iv infusion
                every 12 hours (twice daily) on days 1, 3, and 5 for a total of six doses per
                course. After the four courses of Cytarabine therapy, patients will receive two
                monthly treatments with Cytarabine (200 mg/m2/day by a 3-hour iv infusion for 5
                days) and Daunorubicin (45 mg/m2 by rapid iv infusion on the first treatment day).

             -  If patients have HLA-matched sibling or unrelated donors, allogeneic stem cell
                transplantation will be performed.

             -  A complete remission will be defined as ≤ 5% blasts in a normocellular bone marrow
                with ANC ≥ 1,500/μl and platelets ≥ 100,000/μl in the peripheral blood and the
                disappearance of all blasts in bone marrow.
    

Intervention name(s): arm II
Intervention type(s): Drug
Intervention description(s): Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days
Other intervention name(s): regular dose of Daunorubicin (Arm I); higher dose of Daunorubicin (ArmI)
Intervention MeSH terms: Daunorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment