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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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
ACUTE MYELOGENOUS LEUKEMIA Drug: arm II Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Other Names:
  • regular dose of Daunorubicin (Arm I)
  • higher dose of Daunorubicin (ArmI)




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
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Principal Investigator: Je Hwan Lee, professor Asan Medical Center, ROK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT00474006     History of Changes
Other Study ID Numbers: C-006
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Daunorubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action