High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML
ADcomparison
A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA
1 other identifier
interventional
398
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 15, 2007
CompletedFirst Posted
Study publicly available on registry
May 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 10, 2011
June 1, 2011
7 years
May 15, 2007
June 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
arm I
ACTIVE COMPARATORCytarabine 200 mg/m2/d civ x 7 days Daunorubicin 45 mg/m2/d civ x 3 days
Interventions
Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days
Eligibility Criteria
You may qualify if:
- Patients with newly diagnosed AML or RAEB
- 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
You may not qualify if:
- promyelocytic leukemia or chronic myelogenous leukemia
- significant infection
- prior chemotherapy history for leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Related Publications (1)
Lee JH, Joo YD, Kim H, Bae SH, Kim MK, Zang DY, Lee JL, Lee GW, Lee JH, Park JH, Kim DY, Lee WS, Ryoo HM, Hyun MS, Kim HJ, Min YJ, Jang YE, Lee KH; Cooperative Study Group A for Hematology. A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia. Blood. 2011 Oct 6;118(14):3832-41. doi: 10.1182/blood-2011-06-361410. Epub 2011 Aug 9.
PMID: 21828126DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Je Hwan Lee, professor
Asan Medical Center, ROK
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
May 15, 2007
First Posted
May 16, 2007
Study Start
August 1, 2001
Primary Completion
August 1, 2008
Study Completion
April 1, 2010
Last Updated
June 10, 2011
Record last verified: 2011-06