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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT04622956
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia and chronic myeloid leukemia in complete morphologic remission, myelodysplastic syndrome with less than 10% in bone marrow or peripheral blood, Ph-negative acute lymphoblastic leukemia in complete morphologic remission, chemosensitive Hodgkin lymphoma or non-Hodgkin lymphoma in at least partial remission
* Donor type: haploidentical related donor
* Graft source: bone marrow or peripheral blood
* Recipients of non-myeloblative or myeloablative intensity conditioning
* Left Ventricle Ejection fraction \> 40%
* Estimated creatinine clearance \> 40 mL/min
* Adjusted DLCO ≥ 40% and FEV1 ≥ 40%
* Total bilirubin \< 2x ULN e ALT/AST \< 2.5x ULN
Exclusion Criteria:
* Prior allogeneic transplant
* Ex-vivo graft manipulation (T-cell-depleted or CD34-selected grafts)
* Use of alemtuzumab or anti-thymocyte globulin
* KPS \< 70%
* Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
* Pregnant or lactating women
* Patients seropositive for human immunodeficiency virus (HIV) or active hepatitis B or C infection by PCR
* Presence of fluid collection (ascites, pleural or pericardial effusion) that may interfere with methotrexate clearance or make methotrexate use contraindicated
* Patients with a serious medical or psychiatric illness likely to interfere with participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04622956
Study Brief:
Protocol Section:
NCT04622956