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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT02158767
Eligibility Criteria:
Inclusion Criteria:
* Patients who received a prior hematopoietic progenitor cell transplantation, including matched sibling and unrelated donor transplants, mismatched sibling and unrelated donor transplants and haploidentical transplants from related donors
* Patients with a presence of secondary engraftment failure defined as decrease in donor chimerism by ≥ 50% (i.e. 40% to 20%) in two measurements done at least 30 days apart
* OR a presence of incomplete graft function manifested by presence of persistent or new cytopenias 60 or more days after transplantation:
* Anemia; hemoglobin less than 8g/dL, or red blood cell transfusion requirements over the preceding 4 weeks
* Neutropenia, with absolute neutrophil count less than 1,000 neutrophils per microliter or requirement of growth factor support over the preceding 4 weeks
* Thrombocytopenia, with platelet counts below 20,000 platelets per microliter or platelet transfusion requirements over the preceding 4 weeks
Exclusion Criteria:
* Patients for whom hematopoietic progenitor cells from the original donor are not available
* Presence of reversible causes of engraftment failure or incomplete graft function, including
* Active viral infection
* Medications
* Acute or chronic graft versus host disease (GVHD) that is not controlled to less or equal than stage II with immunosuppressants
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT02158767
Study Brief:
Protocol Section:
NCT02158767