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

Cooperative Study Group A for Hematology

Status and phase: Unknown; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: FLAG+IDA

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00559221

C-007A

Details and patient eligibility

About

• 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

Full description

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

Enrollment: 37 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

1

No Intervention group

Treatment:

Drug: FLAG+IDA