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 : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 30, 2022
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|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|
|Actual Study Start Date :||April 1, 2021|
|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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Day to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;
- AML: History of AML induction/reinduction Failure (<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML
- High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission
5. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function
- Females who are pregnant or breast-feeding are not eligible.
- Patients with documented uncontrolled infection at the time of study entry are not eligible.
- Karnofsky/Lansky (age appropriate) Performance Score <60
- Demonstrated lack of compliance with medical care
- Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.
- Patients with active <Grade 2 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, MDfirstname.lastname@example.org|
|Contact: Lauren Harrison, RNemail@example.com|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell S Cairo, MD 914-594-2150 firstname.lastname@example.org|
|Contact: Lauren Harrison, MSN 6172857844 email@example.com|
|Study Chair:||Mitchell S Cairo||New York Medical College|
|Responsible Party:||Mitchell Cairo, Co-Investgiator, New York Medical College|
|Other Study ID Numbers:||
|First Posted:||September 23, 2019 Key Record Dates|
|Last Update Posted:||September 30, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
allogeneic stem cell transplantation
alpha beta cell depletion
Anemia, Sickle Cell
Neoplasms by Histologic Type
Immune System Diseases
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Blood Platelet Disorders
Bone Marrow Failure Disorders
Bone Marrow Diseases
Anemia, Hypoplastic, Congenital
Red-Cell Aplasia, Pure
Congenital Bone Marrow Failure Syndromes