Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01063660
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01063660
Study Brief:
Protocol Section:
NCT01063660