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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT01773395
Eligibility Criteria:
Inclusion Criteria:
* AML, CMML-with excess blasts, MDS-RAEB not in remission prior to leukemia cell harvest
* HLA 8/8 or 7/8 matched related or unrelated donor available
* ECOG performance status of 0-2
* Suitable candidate for myeloablative or reduced intensity conditioning allogeneic HSCT using PBSC or marrow as stem cell resource
* Normal organ function
Exclusion Criteria:
* Pregnant or breastfeeding
* Leukemia with active CNS involvement
* Positive HIV or HTLV-1 serology
* History of allergic reactions to compounds of similar chemical or biologic composition to GM-CSF
* Uncontrolled intercurrent illness
* History of different malignancy except if disease free for at least two years or cervical cancer in situ, basal or squamous cell carcinoma of the skin diagnosed and treated within the past two years
* Prior allogeneic transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01773395
Study Brief:
Protocol Section:
NCT01773395