The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system is currently approved for use in patients who have AML, and a genetically matched sibling donor. Through this protocol, the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor, who have no other options for treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Stanford Children's Hospital
Palo Alto, California, United States
Number of Patients With Severe (Grade III/IV) Acute Graft vs Host Disease (GVHD)
GVHD is a condition that occurs when donor bone marrow or stem cells attack the recipient.
Time frame: Day +100
Number of Participants With Graft Failure
Failure of donor stem cells to make neutrophils
Time frame: Up to Day +42 after stem cell transplant
Length of Time to Engraftment
Absolute neutrophil count (ANC) \>500 for 3 consecutive days and \>80% donor cells in blood.
Time frame: up to +1 year post-transplant
Chimerism of Donor Cells
The percentage of donor cells for all evaluable (without disease progression) patients
Time frame: Day +100 post-transplant
Immune Recovery (CD4)
The time to CD4 count \>100
Time frame: up to +1 year post-transplant
Number of Participants With Immune Recovery (CD4 >200) by Year 1
Time frame: up to +1 year post-transplant
Immune Recovery Shown as Phytohemagglutin (PHA)
Immune recovery defined as achieving normal levels of PHA (53,000-200,000 CPM)
Time frame: 6 months and 1 year post-transplant
Number of Patients With Post-transplant Lymphoproliferative Disease (PTLD)
Post-transplant lymphoproliferative disorder (PTLD) is a well-known, life-threatening complication of organ transplantation, predominantly occurring after solid organ transplantation (SOT) and hematopoietic stem cell transplantation (HSCT).
Time frame: up to +1 year post-transplant
Number of Patients With Severe Toxicities
Incidence of transplant-related toxicities
Time frame: up to +1 year post-transplant
Number of Participants Experiencing Post-transplant Infections
Post-transplant infections will be described by incidence and type. Participants may have had more than one type of infection.
Time frame: up to +1 year post-transplant
Transplant-related Mortality (TRM)
Death related to transplant
Time frame: at Day +100 and +1 year post-transplant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.