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Phase 2
60 Years
80 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

- A second course of induction chemotherapy can be given to the patient when a partial
remission but less than a complete remission is achieved after the first course. At
least 4 weeks should be apart between start of the first course and start of the second

- G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of
hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute
neutrophil counts are 1,000/l or more.

- For the patients who achieve a complete remission, consolidation therapy will be given
as follows:

- Two more cycles of the same chemotherapy will be given to the patients who achieve
a complete remission after single induction course. Allogeneic or autologous
hematopoietic cell transplantation could be also considered.

- In patients who relapse after allogeneic hematopoietic cell transplantation, donor
leukocyte infusion will be done without consolidation chemotherapy.

- In patients who had extramedullary relapse(s), local radiotherapy can be given to
the relapse site(s).

Inclusion Criteria:

- Failure to achieve CR after initial induction chemotherapy

- Any relapse, regardless of the frequency and time of relapse from first CR

- Relapse after hematopoietic cell transplantation, allogeneic or autologous.

- Multiple relapses, extramedullary relapse(s)

Exclusion Criteria:

- Inadequate hepatic,renal,cardiac function

- Psychiatric disorder or mental deficiency

- CNS involvement of leukemic blasts

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate, duration of complete remission, toxicities

Principal Investigator

Hawk Kim, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ulsan University Hospital, ROK


Korea: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

October 2007

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid