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


Phase 3
15 Years
60 Years
Not Enrolling
Both
ACUTE MYELOGENOUS LEUKEMIA

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicities, complete remission rate, duration of complete remission, disease-free survival, overall survival

Outcome Description:

The effects will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Outcome Time Frame:

10years

Safety Issue:

Yes

Principal Investigator

Je Hwan Lee, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center, ROK

Authority:

Korea: Food and Drug Administration

Study ID:

C-006

NCT ID:

NCT00474006

Start Date:

August 2001

Completion Date:

April 2010

Related Keywords:

  • Acute Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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