Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during induction and consolidation courses versus no priming.

2. To compare as consolidation timed sequential chemotherapy versus four courses of high dose cytarabine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acute Leukemia French Association
• Collaborator: Hospices Civils de Lyon
• Treatments: Cytarabine; Daunorubicin; Etoposide; Mitoxantrone; Molgramostim; Sargramostim

Criteria

Inclusion Criteria:

• A morphologically proven diagnosis of AML according to the WHO classification

• Serum creatinine < 2N; AST and ALT < 2.5N; total bilirubin < 2N (unless related to the underlying disease).

• ECOG performance status 0 to 2.

• Women of child-bearing must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.

• Must be able and willing to give written informed consent

Exclusion Criteria:

• Patients with M3-AML. Patient with AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).

• Patient presenting any diagnosis of uncontrolled or metastatic tumor.

• Patients with uncontrolled severe infection,