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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00306332
Eligibility Criteria:
Inclusion Criteria:
* Patients with the diagnosis of:
* De novo acute myeloid leukaemia in first or second remission.
* Secondary acute myeloid leukaemia in first or second remission supervening after myelodysplastic syndrome or cytotoxic / immunosuppressive therapy.
* Acute lymphoblastic leukaemia in first or second remission.
* Myelodysplastic syndrome.
* Chronic myeloid leukaemia, patients who are candidate for SCT.
* Malignant lymphoma following relapse or first line therapy resistant.
* Aggressive mantle cell lymphoma in first complete remission.
* Age 18-65 years.
* WHO performance 0-1 (see appendix ).
* Availability of an HLA-identical sibling or HLA, A, B, DRB, DQB -identical VUD donor.
* Life expectancy \> 3 months.
* Witnessed written informed consent.
Exclusion Criteria:
* Patients with severe cardiac dysfunction (NYHA-classification II-IV)
* Patients with severe pulmonary dysfunction (vital capacity or diffusion \< 70% of predicted value).
* Patients with hepatic dysfunction, bilirubin or transaminases \> 2.5 x upper normal limit
* Patients with renal dysfunction, serum creatinin \> 150 umol/liter or clearance \< 40 ml/minute.
* Patients with a history of moderate ore severe CNS disturbances and psychiatric problems.
* Prior treatment with chemotherapy, immunotherapy, radiation therapy or surgery within the last 3 weeks before entering the study.
* Patients with active uncontrolled infections.
* Patients who are poor medical risks because of non malignant systemic disease.
* Patients with severe coagulopathy.
* Patients to be known HIV positive.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00306332
Study Brief:
Protocol Section:
NCT00306332