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Effect of Priming With Granulocyte-Macrophage Colony-Stimulating Factor During Chemotherapy and Comparison of Timed Sequential Chemotherapy vs 4 Courses of High Dose Cytarabine as Consolidation in Younger Adults With Newly Diagnosed AML


Phase 3
15 Years
50 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

Effect of Priming With Granulocyte-Macrophage Colony-Stimulating Factor During Chemotherapy and Comparison of Timed Sequential Chemotherapy vs 4 Courses of High Dose Cytarabine as Consolidation in Younger Adults With Newly Diagnosed AML


Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during
all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy
consists of a timed-sequential chemotherapy including a first sequence of chemotherapy
combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days
(days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same
period. The second sequence, administered after 4-day free interval, consists of
mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and
9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10).
Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine,
100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia
Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day,
intravenously beginning at day 1 of each chemotherapy course and continuing until the last
day of chemotherapy of each course.

Patients who achieve CR after induction chemotherapy or salvage therapy are randomly
assigned to consolidation courses consisting of either a timed sequential chemotherapy
similar to that of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1
arm), which includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance
courses.


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,

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessing the potential value of the daily administration of GM-CSF during induction chemotherapy and post-induction for analyzing and comparing the arms with and without GM-CSF: EFS, % of CR, duration of remission, OS and toxicity of each treatment.

Outcome Time Frame:

72 months

Safety Issue:

No

Principal Investigator

XAVIER THOMAS, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ALFA 9802

NCT ID:

NCT00880243

Start Date:

March 1999

Completion Date:

September 2006

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • Priming
  • GM-CSF
  • Timed-sequential chemotherapy
  • Prognosis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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