Trial | NCT00474006  Report issue

Title

High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML
A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    398
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.
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.

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.

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.
Study Started
Aug 31
2001
Primary Completion
Aug 31
2008
Study Completion
Apr 30
2010
Last Update
Jun 10
2011
Estimate

Drug arm II

Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days

  • Other names: regular dose of Daunorubicin (Arm I), higher dose of Daunorubicin (ArmI)

arm I Active Comparator

Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 45 mg/m2/d civ x 3 days

Criteria 

Inclusion Criteria:

Patients with newly diagnosed AML or RAEB
15 years of age or older, but younger than 60 years of age
Adequate hepatic and renal function
Normal cardiac function with LVEF ≥ 50% on MUGA scan or echocardiogram
Written informed consent

Exclusion Criteria:

promyelocytic leukemia or chronic myelogenous leukemia
significant infection
prior chemotherapy history for leukemia
No Results Posted