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. - ND

• Conditions: Adults with acute myelogenous leukaemia (AML) in first complete remission (CR1); MedDRA version: 9.1Level: PTClassification code 10000881

• Registration Number: EUCTR2009-016601-42-IT
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-26
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

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 < o = 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 > o = 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 > o = 50% or shortening fraction > o = 30%. Pulmonary: no symptomatic pulmonary disease. Adequate pulmonary function tests : Forced Expiratory Volume in 1 sec (FEV1) / Forced Vital Capacity (FVC) ratio > o = 60 % of expected (corrected for haemoglobin), or diffusing capacity of lung for carbon monoxide (DLCO) > o = 50% of predicted. Hepatic function: transaminases (ALT, AST) each < o = 2 upper normal limit (UNL). Total bilirubin < o = 1.5 x UNL. Renal function: serum creatine < o = 1.5 x UNL or creatinine clearance measured by EDTA or calculated > o = 75 % of normal. Viral serology: negative serology for Hepatitis B (Ag), C and HIV. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient. Central venous access secured through an indwelling catheter. Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 6 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment. Fertile men must be using an effective method of birth control if their partners are women of childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 6 months following the last dose of study treatment. Patient not available for follow-up assessments. Treatment with any investigational drug within the 30 days prior to registration, and up to thirty days after the study treatment administration. Clinically relevant cardiovascular, neurological or other systemic disease making implementation of the protocol difficult.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified