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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT01350258
Eligibility Criteria:
Inclusion Criteria:
1. Any patient with a high-risk hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. High risk is defined as:
* Acute leukemia in 3rd or greater CR or with persistent disease
* Myelodysplastic syndrome (MDS) other than RA or RARS subtypes.
* Hodgkin's or Non-Hodgkin's lymphoma in 3rd or greater remission or with persistent disease.
* Myeloma in 3rd or greater remission or with less than PR to most recent therapy.
* Chronic myelogenous (or myeloid) leukemia (CML) resistant to STI therapy
2. Patients must have a related donor who is at least a 4 antigen match at the HLA-A; B; C; DR loci.
3. Patients must adequate organ function:
* LVEF of \> or = 50%
* DLCO \> or = 50% of predicted corrected for hemoglobin
* Adequate liver function as defined by a serum bilirubin \< or = 1.8, AST or ALT \< or = 2.5X upper limit of normal
* GFR of \> or = 60 mL/min/1.73m2
4. Performance status \> or = 80% (TJU Karnofsky) for patients \> or = 60 years old or \> or = 70% for patients \< 60.
5. HCT-CI Score \< or = 4 points for patients \> or = 60 years old or \< or = 5 points for patients \< 60.
6. Patients must be willing to use contraception if they have childbearing potential
7. Able to give informed consent
Exclusion Criteria:
1. Performance status \< 80% (TJU Karnofsky) for patients \> or = 60 years old or \< 70% for patients \< 60.
2. HCT-CI Score \> 4 points for patients \> or = 60 years old or \> 5 points for patients \< 60.
3. HIV positive
4. Active involvement of the central nervous system with malignancy
5. Inability to obtain informed consent
6. Pregnancy
7. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder
8. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit ant-thymocyte globulin and have an ATG level of \> or = 2 ugm/ml
9. Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Donor Selection All donors are selected and screened for their ability to provide adequate infection-free apheresis products for the patient in a manner that does not put the donor at risk for negative consequences. Donor selection will be in compliance with 21 CFR 1271 and TJU BMT Program SOP CP: P009.03.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01350258
Study Brief:
Protocol Section:
NCT01350258