Stanford Children's Hospital
Palo Alto, California, 94305, United States
NCT Number: NCT02162511
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.
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Notify MeUp to 35 year
All sexes
Interventional
Not applicable
Palo Alto, California, 94305, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day +100
GVHD is a condition that occurs when donor bone marrow or stem cells attack the recipient.
Time frame: Up to Day +42 after stem cell transplant
Failure of donor stem cells to make neutrophils
Time frame: up to +1 year post-transplant
Absolute neutrophil count (ANC) >500 for 3 consecutive days and >80% donor cells in blood.
Time frame: Day +100 post-transplant
The percentage of donor cells for all evaluable (without disease progression) patients
Time frame: up to +1 year post-transplant
The time to CD4 count >100
Time frame: up to +1 year post-transplant
Time frame: 6 months and 1 year post-transplant
Immune recovery defined as achieving normal levels of PHA (53,000-200,000 CPM)
Time frame: up to +1 year post-transplant
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
Incidence of transplant-related toxicities
Time frame: up to +1 year post-transplant
Post-transplant infections will be described by incidence and type. Participants may have had more than one type of infection.
Time frame: at Day +100 and +1 year post-transplant
Death related to transplant
Rajni Agarwal
Other
An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.