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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT00856505
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
* acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
* chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
* myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
* Lymphoma:
* plasmocytoma
* immunocytoma (M. Waldenström)
* chronic-lymphatic leukemia (CLL)
* additional low and high grade Non-Hodgkin Lymphoma
* Hodgkins disease
* HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
* Signed informed consent
Exclusion Criteria:
* CNS involvement by underlying disease
* Pulmonary disease with VC \< 55%, DLCO \< 40%
* Cardiac ejection fraction \< 30%, uncontrollable arrhythmia
* Creatinin \> 1,5 mg/dl or Creatinin-Clearance \< 30 ml/min
* Bilirubin \> 2 mg/dl
* Active Hepatitis B or C
* HIV serologic positive
* Pregnancy and lactation
* Pre-menstrual women without medical safe contraception
* Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.
* Known allergy to study medication or ingredients of the formulation
* Drug- or alcohol abuse
* Non-compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00856505
Study Brief:
Protocol Section:
NCT00856505