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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880243
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospices Civils de Lyon
Information provided by:
Acute Leukemia French Association
  Purpose

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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: GM-CSF Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Acute Leukemia French Association:

Primary Outcome Measures:
  • 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. [ Time Frame: 72 months ]

Secondary Outcome Measures:
  • Evaluate the effectiveness on DFS of a single course of consolidation using a very intensive sequential chemotherapy with mitoxantrone, AraC and etoposide feasible compared to 4 courses of high dose AraC followed of 4 courses of maintenance. [ Time Frame: 72 months ]

Enrollment: 473
Study Start Date: March 1999
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMA+GM-CSF
  • Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3,
  • AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3,
  • Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9
  • AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10.
  • GM-CSF (LeucomaxR): 5 µg/kg/jour IV over 6 hours from day 1 to day 10.
Drug: GM-CSF

Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.

Randomiization 2: Consolidation high dose AraC versus consolidation EMA

Other Names:
  • GM-CSF: molgramostim
  • AraC: Cytarabine
  • Daunorubicine: Cerubidine
  • EMA: etoposide, mitoxantrone, cytarabine
Active Comparator: EMA without GM-CSF
  • Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3,
  • AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3,
  • Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9
  • AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10.
Drug: GM-CSF

Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.

Randomiization 2: Consolidation high dose AraC versus consolidation EMA

Other Names:
  • GM-CSF: molgramostim
  • AraC: Cytarabine
  • Daunorubicine: Cerubidine
  • EMA: etoposide, mitoxantrone, cytarabine
Experimental: HD AraC+ GM-CSF
  • AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5
  • GM-CSF :5 µg/kg/d IV (6 hours) from day1 to day 5
Drug: GM-CSF

Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.

Randomiization 2: Consolidation high dose AraC versus consolidation EMA

Other Names:
  • GM-CSF: molgramostim
  • AraC: Cytarabine
  • Daunorubicine: Cerubidine
  • EMA: etoposide, mitoxantrone, cytarabine
Active Comparator: HD-AraC without GM-CSF
- AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5
Drug: GM-CSF

Randomization 1: GM-CSF (5micogram/Kg/d) versus no GM-CSF during induction chemotherapy and all consolidation courses.

Randomiization 2: Consolidation high dose AraC versus consolidation EMA

Other Names:
  • GM-CSF: molgramostim
  • AraC: Cytarabine
  • Daunorubicine: Cerubidine
  • EMA: etoposide, mitoxantrone, cytarabine

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880243


Sponsors and Collaborators
Acute Leukemia French Association
Hospices Civils de Lyon
Investigators
Principal Investigator: XAVIER THOMAS, MD, PhD Hospices Civils de Lyon
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xavier THOMAS, MD, PhD, Service Hematologie, LYON, France
ClinicalTrials.gov Identifier: NCT00880243     History of Changes
Other Study ID Numbers: ALFA 9802
First Submitted: April 8, 2009
First Posted: April 13, 2009
Last Update Posted: April 13, 2009
Last Verified: April 2009

Keywords provided by Acute Leukemia French Association:
Acute myeloid leukemia
Priming
GM-CSF
Timed-sequential chemotherapy
Prognosis

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Mitoxantrone
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic