Study on GM-CSF and Post-Transplant Cyclophosphamide for Patients Undergoing Stem Cell Transplant
Sponsor: Northside Hospital, Inc.
ClinicalTrials ID:NCT04237623
This clinical trial is exploring whether using GM-CSF after a stem cell transplant can help improve recovery and reduce infection risks in patients receiving a specific type of transplant with post-transplant cyclophosphamide.
Patient Parameters
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Program Overview
The study aims to find out if giving GM-CSF after a stem cell transplant can help patients recover their blood cell counts as effectively as the current standard treatment, G-CSF, while potentially reducing the risk of infections. This is particularly important for patients undergoing a type of transplant called HLA-mismatched haploidentical transplantation, which is known to have a higher risk of infections.
Eligibility Criteria
Inclusion Criteria
- Have a related donor who is a 5/10 to 8/10 match for the transplant.
- Have a Karnofsky Performance Status (KPS) score of 70% or higher, indicating the ability to care for oneself with some assistance.
- Diagnosed with certain blood-related conditions such as Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), Myelodysplastic Syndromes (MDS), Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hodgkin's Disease (HD), Non-Hodgkin's Lymphoma (NHL), Myeloproliferative Syndromes (MPS), Chronic Myelomonocytic Leukemia (CMML), Multiple Myeloma (MM), or any other blood condition that qualifies for an allogeneic transplant according to the treating center.
Exclusion Criteria
- Have poor heart, lung, liver, or kidney function.
- Are HIV-positive.
- Have a serious medical or psychiatric condition that prevents them from giving informed consent.
- Have a history of severe allergic reactions to human GM-CSF or products derived from yeast.
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