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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT06799195
Eligibility Criteria:
Inclusion criteria:
* Adults aged 60 years or older
* Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation
* Planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (HLA)-matched donor at HLA loci A, B, C, and HLA-DR beta chain antigen (DRB1)
* Karnofsky Performance Status (KPS) of 70% or higher.
Exclusion criteria:
* Previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant)
* Planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg/kg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. A lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg/kg) is acceptable.
* Known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism.
* Diagnosis of myelofibrosis
* Creatinine clearance less than 40 mL/min/1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (PTCy)
* Systolic cardiac dysfunction with an ejection fraction of less than 45%.
* Use of a haploidentical or mismatched donor.
* Any other condition judged by the physician to increase the risk of toxicities associated with PTCy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06799195
Study Brief:
Protocol Section:
NCT06799195