High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML (ADcomparison)
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|ClinicalTrials.gov Identifier: NCT00474006|
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|ACUTE MYELOGENOUS LEUKEMIA||Drug: arm II||Phase 3|
- 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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||398 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||April 2010|
Active Comparator: arm I
Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 45 mg/m2/d civ x 3 days
Drug: arm II
Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days
- Toxicities, complete remission rate, duration of complete remission, disease-free survival, overall survival [ Time Frame: 10years ]The effects will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474006
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa-gu, Korea, Republic of, 138-736|
|Principal Investigator:||Je Hwan Lee, professor||Asan Medical Center, ROK|