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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00217594
Eligibility Criteria:
* INCLUSION CRITERIA:
1. MDS with WHO classification of RA, RARS, RCMD-RS, RCUD, and RCMD and RAEB-1 (all subtypes of MDS with the exception of RAEB 2, CMML, and MDS/MPN overlap)
2. Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months
OR
Anemia (hemoglobin less than 9 or a reticulocyte count less than 60,000)
OR
thrombocytopenia (platelet count less than 50000/ul)
OR
neutropenia (absolute neutrophil count less than 500/ul).
3. Off all other treatments for MDS (except filgrastim (G-CSF), erythropoietin, and transfusion support and related medications) for at least four weeks. Filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/Ul) as long as they meet the criteria for anemia and/or thrombocytopenia as stated above.
4. Ages 18-72 (inclusive)
EXCLUSION CRITERIA:
1. Chronic myelomonocytic leukemia (CMML), MDS/MPN overlap, WHO RAEB-2
2. Secondary MDS
3. Failure to respond to prior therapy with ATG or ATG/CsA
4. Prior therapy with combination chemotherapy
5. Transformation to acute leukemia (FAB sub-group RAEB-T, i.e., greater than 20% blasts in marrow aspirate)
6. Failure to discontinue the herbal supplements Echinacea purpurea or Usnea barbata (Old Man's Beard) within 2 weeks of enrollment.
7. Active infection not adequately responding to appropriate therapy
8. HIV positive patients
9. Active malignant disease (excluding non-melanoma skin carcinoma)
10. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy or that death within 7-10 days is likely.
11. Life expectancy less than 6 months
12. Low predicted probability of response
13. Previous hypersensitivity to alemtuzumab (Campath\[R\]) or its components
14. Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
15. Not able to understand the investigational nature of the study or give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT00217594
Study Brief:
Protocol Section:
NCT00217594