Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Location status: Recruiting
Location contact
Hemalatha Rangarajan, MD
CONTACT
Rolla Abu-Arja, MD
CONTACT
Rolla Abu-Arja, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06082947
This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.
Interested in participating?
Request InfoUp to 30 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43205, United States
Location status: Recruiting
Hemalatha Rangarajan, MD
CONTACT
Rolla Abu-Arja, MD
CONTACT
Rolla Abu-Arja, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CliniMACS® αβT cell/CD19+B cell depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)
Time frame: 1 year
One-year overall survival of patients undergoing allogeneic HSCT
Time frame: 100 days
Neutrophil and platelet engraftment by day 100
Time frame: 1 year
Incidence of final status graft failure by 1 year
Time frame: 1 year
Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year
Time frame: 1 year
Incidence of chronic GVHD by 1 year
Time frame: 1 year
100 day and 1 year Transplant related mortality by 1 year
Time frame: 1 year
1 year Event free survival
Contact information is provided by the study sponsor or research team.
Clelie Peck
CONTACT
Lauren Rayman
CONTACT
Nationwide Children's Hospital
Other
αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) for Children and Young Adults With Hematologic Malignancies
Acronym: TB19DHCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
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