High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML

ACUTE MYELOGENOUS LEUKEMIA Clinical Trial

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Official title:

A RANDOMIZED COMPARISON OF TWO DIFFERENT DOSAGES OF DAUNORUBICIN IN INDUCTION TREATMENT OF ACUTE MYELOGENOUS LEUKEMIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474006
• Other study ID #: C-006
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2007
• Last updated: June 8, 2011
• Start date: August 2001
• Est. completion date: April 2010

Study information

• Verified date: June 2011
• Source: Cooperative Study Group A for Hematology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: April 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACUTE MYELOGENOUS LEUKEMIA
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• arm II
Cytarabine 200 mg/m2/d civ x 7 days Daunorubicin 90 mg/m2/d civ x 3 days

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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