AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
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|ClinicalTrials.gov Identifier: NCT04099966|
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : February 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia Severe Aplastic Anemia Non-hodgkin Lymphoma Hodgkin Lymphoma Kostmann Diamond Blackfan Anemia Amegakaryocytic Thrombocytopenia Sickle Cell Disease Beta-Thalassemia||Drug: alpha beta depletion||Phase 2|
Patients wiith selected malignant or non-malignant conditions meeting eligibility criteria will be enrolled on this study. Patients will receive one of either full intensity, reduced intensity, or reduced toxicity conditioning appropriate based on disease, disease status, organ function and performance status and will undergo α/β T-cell and CD 19+ B cell depleted alloSCT.
Patients will be following for engraftment, chimerism, immune reconstitution, GVHD and QOL.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: alpha beta cell depletion
Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.
Drug: alpha beta depletion
donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
Other Name: α/β CD3+/CD19+ cell depletion
- incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells [ Time Frame: 1 year ]patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
- incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]patients will have routine chimerism performed to monitoring engraftment of donor cells
- incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]patients will be monitored post transplant for signs of acute and chronic GVHD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099966
|Contact: Mitchell S Cairo, MDemail@example.com|
|Contact: Lauren Harrison, RNfirstname.lastname@example.org|
|United States, New York|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|Study Chair:||Mitchell S Cairo||New York Medical College|