High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML
- Conditions
- ACUTE MYELOGENOUS LEUKEMIA
- Interventions
- Drug: arm II
- Registration Number
- NCT00474006
- Lead Sponsor
- Cooperative Study Group A for Hematology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
- 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
- promyelocytic leukemia or chronic myelogenous leukemia
- significant infection
- prior chemotherapy history for leukemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm I arm II Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 45 mg/m2/d civ x 3 days
- Primary Outcome Measures
Name Time Method Toxicities, complete remission rate, duration of complete remission, disease-free survival, overall survival 10years The effects will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of