Status:
COMPLETED
Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)
Lead Sponsor:
Acute Leukemia French Association
Collaborating Sponsors:
Hospices Civils de Lyon
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
15-50 years
Phase:
PHASE3
Brief 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 conso...
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 tim...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00880243
Start Date
March 1 1999
End Date
September 1 2006
Last Update
April 13 2009
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