FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559221

Enrollment

Registered

2007-11-16

Start date

2004-12-31

Completion date

2008-06-30

Last updated

2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

AML

Brief summary

\- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

Detailed description

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

Interventions

DRUGFLAG+IDA

Fludarabine, cytarabine, G-CSF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete remission rate, duration of complete remission, toxicities	06/2008

Secondary

Measure	Time frame
progression-free survival, overall survival	06/2008

Countries

South Korea

Contacts

Primary ContactYae-Eun Jang, nurse

redpin75@paran.com80-2-3010-7290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026