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Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia


Phase 2
15 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

Fludarabine and Cytarabine as Continuous Infusion Plus Idarubicin With Granulocyte-Colony Stimulating Factor (G-CSF) Priming for Patients Younger Than 60 Years With Resistant Acute Myeloid Leukemia


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


Inclusion Criteria:



- Failure to achieve CR after initial induction chemotherapy including standard
dose cytarabine.

- Early relapse, occurring after a first CR lasting less than 12 months.

- Patients with multiple relapses will be included.

- Written informed consent must be given.

- 15 and 60 years of age.

- 2 or less by ECOG performance scale.

Exclusion Criteria:

- acute promyelocytic leukemia

- pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete remission rate, duration of complete remission, toxicities

Outcome Time Frame:

06/2008

Principal Investigator

Hawk Kim, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ulsan Universtity Hospital, ROK

Authority:

Korea: Food and Drug Administration

Study ID:

C-007A

NCT ID:

NCT00559221

Start Date:

December 2004

Completion Date:

June 2008

Related Keywords:

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

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