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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT03850366
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
* Candidate for stem cell transplant in a malignant hematological condition
* Karnofsky Performance Scale 0-1
* Available donor able to undergo a Peripheral blood stem cells collection
* Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
* Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
* Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
* Left ventricle ejection fraction \> 40%.
* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.
Exclusion Criteria:
* Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
* HIV positive; active hepatitis B or C
* Patients with active uncontrolled infections.
* Liver cirrhosis
* Uncontrolled central nervous system involvement by tumor cells
* Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
* Inability to comply with medical therapy or follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03850366
Study Brief:
Protocol Section:
NCT03850366