Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukaemia
Inclusion Criteria:
- Patients with acute myeloid leukaemia (AML) according to WHO classification (> 20%
myeloblasts in peripheral blood or bone marrow at initial diagnosis) with < 5%
myeloblast in the bone marrow, indicated for allogeneic transplantation
- Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor
(MUD) HLA-identity defined by the following markers: A, B, DRB1, DQB1.
- Target graft size (unmanipulated)
- bone marrow: 2 - 10 x 106 CD34+ cells/kg BW recipient or > 2 x 108 nucleated cells/kg
BW recipient or
- peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient
- Age > 18 and < 60 years
- Karnofsky Index > 80 %
- Adequate contraception in female patients of child-bearing potential
- Written informed consent
Exclusion Criteria:
- Therapy related secondary AML
- AML with t(8;21)(q22;q22) in CR1
- Acute promyelocytic leukaemia with t(15;17)(q22;q12) in CR1
- Secondary malignancies
- Previous allogeneic transplantation
- Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or
cardiac function)
- Known and manifested malignant involvement of the CNS
- Active infectious disease
- HIV- positivity or active hepatitis infection
- Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper
normal limit)
- Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x
upper normal limit).
- Pleural effusion or ascites > 1.0 L
- Pregnancy or lactation
- Known hypersensitivity to treosulfan and/or fludarabine
- Participation in another experimental drug trial within 4 weeks before day -6
- Non-co-operative behaviour or non-compliance
- Psychiatric diseases or conditions that might impair the ability to give informed
consent