A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities, complete remission rate, duration of complete remission, disease-free survival, overall survival
The effects will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
10years
Yes
Je Hwan Lee, professor
Principal Investigator
Asan Medical Center, ROK
Korea: Food and Drug Administration
C-006
NCT00474006
August 2001
April 2010
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