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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03480360
Eligibility Criteria:
Inclusion Criteria:
* Age: less than 75 years
* The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP - Pre-transplant Evaluation of allogeneic recipient (Appendix).
* The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:
* Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
* Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
* Myelodysplasia
* Myeloproliferative disorder
* Myelofibrosis
* Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease
* Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia
* Donor availability- the patient must have an identified RELATED haplo-identical donor
* No Human Immunodeficiency Virus infection or active hepatitis B or C
* Eastern Cooperative Oncology Group performance status: 0-2
* Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted
* Left ventricular ejection fraction greater than or equal to 40%
* Serum bilirubin \< 2x upper limit of normal; transaminases \< 3x normal at the time of transplant
* No active or uncontrollable infection
* In female, a negative pregnancy test if experiencing menstrual periods
* No major organ dysfunction precluding transplantation
* No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision).
Exclusion Criteria:
* Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.
* Major anticipated illness or organ failure incompatible with survival from bone marrow transplant.
* History of refractory systemic infection
DONOR ELIGIBILITY
* Human leukocyte antigen (HLA) haplo-identical matched related.
* The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix)
* The donor must have no significant co-morbidities that would put the donor at marked increased risk
* There is no age restriction for the donor
* Informed consent must be signed by donor
DONOR EXCLUSION CRITERIA
* The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible:
* Pregnant or lactating donor
* HIV or active Hep B or C in the donor
* Donor unfit to receive G-CSF and undergo apheresis
* A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03480360
Study Brief:
Protocol Section:
NCT03480360