EUCTR2009-016601-42-FR
Active, not recruiting
Phase 1
A phase II multicentric study in adults with acute myelogenous leukaemia (AML) in first complete remission (CR1) using IV BuCy2 in a once daily Bu regimen targeting a narrow therapeutic window prior to hematopoietic stem cell transplantation.
ConditionsAcute myeloid leukaemiaMedDRA version: 12.1Level: PTClassification code 10000881Term: <Manually entered code. Term in E.1.1>
DrugsBUSILVEX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute myeloid leukaemia
- Sponsor
- PIERRE FABRE MEDICAMENT
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients with acute myelogenous leukaemia are eligible to enter the study if:
- •They are in first complete remission, CR1 (CR is defined as percentage of leukemic blasts \= 5% in BM, recovery of normal neutrophils and normal platelets, no extramedullary disease).
- •They are planned to receive allogeneic HSCT according to center criteria from either HLA matched sibling donor or unrelated donor with HLA compatibility \= 9/10 on HLA A, B, C, DRB1, DQB1\.
- •Age \= 18 years old and \= 55 years.
- •Karnofsky’s performance status \=70%.
- •Comorbidity score: Sorror HCT\-CI \< 3 (see appendix III).
- •Life’s expectancy \> 3 months.
- •Adequate organ system function:
- •Cardiac: no uncontrolled arrhythmias (untreated atrial fibrillation or flutter or ventricular arrhythmia) or symptomatic cardiac diseases (coronary artery disease, congestive heart failure or myocardial infarction). Left Ventricular Ejection Fraction (LVEF) by echocardiogram must be \= 50% or shortening fraction \=30%.
- •Pulmonary: no symptomatic pulmonary disease. Adequate pulmonary function tests : Forced Expiratory Volume in 1 sec (FEV1\) / Forced Vital Capacity (FVC) ratio \=60 % of expected (corrected for haemoglobin), or diffusing capacity of lung for carbon monoxide (DLCO) \= 50% of predicted.
Exclusion Criteria
- •Patient with at least one of the following criteria will not be included:
- •Serious concomitant illness or medical condition: clinical or microbiological evidence of infection.
- •Chronic or active hepatitis or cirrhosis.
- •Unstable concomitant disease.
- •Second transplant requiring dose modification of busulfan.
- •Prior history of hepatic disease.
- •Patient being treated with voriconazole.
- •Patient with hepatic iron overload.
- •Known hypersensitivity to drugs of similar chemical structures to study medication.
- •A female is not eligible to enter the study if she is pregnant or lactating or has a positive pregnancy test at inclusion.
Outcomes
Primary Outcomes
Not specified
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