Actively Recruiting
Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588
Led by Mitchell Cairo · Updated on 2025-08-08
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study children, adolescents, and young adults up to 30 years old who have malignant or non-malignant blood disorders and are undergoing allogeneic stem cell transplantation (AlloSCT). The trial focuses on selecting stem cells using alpha/beta T cell and CD19+ B cell depletion techniques. The purpose is to evaluate outcomes related to this specialized cell selection method in these patients. Participants will receive conditioning treatment before transplantation that may be full intensity, reduced intensity, or reduced toxicity based on their disease, status, organ function, and performance. They will then undergo AlloSCT with stem cells processed using alpha/beta CD3+/CD19+ cell depletion via the Prodigy system. Standard pre-conditioning and post-transplant monitoring will be provided throughout the study. During the study, participants will be monitored for engraftment success, immune system recovery, graft-versus-host disease (GVHD), and quality of life. Researchers will track adverse events related to the cell-depleted stem cell administration over one year. The total involvement includes regular evaluations and follow-up to assess treatment effects and safety over a 12-month period.
CONDITIONS
Brief Title
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children, adolescents, and young adults aged 0 to 30 years
- Diagnosed with high-risk acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), Hodgkin or Non-Hodgkin lymphoma, or bone marrow failure syndromes such as Kostmann syndrome, Diamond-Blackfan anemia, or amegakaryocytic thrombocytopenia
- Diagnosed with sickle cell disease including Homozygous Hemoglobin S Disease, Hemoglobin S beta 0/+ thalassemia, or Hemoglobin SC Disease
- Adequate organ function to undergo transplantation
- Meet disease-specific criteria for remission, relapse, or therapy resistance as detailed in the protocol
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Patients with uncontrolled infection at study entry
- Karnofsky or Lansky performance score less than 60
- Demonstrated lack of compliance with medical care
- Patients who received allogeneic hematopoietic stem cell transplant within 6 months unless as a booster
- Patients with active graft-versus-host disease less than Grade 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on conditioning regimen and transplant process
Participants will receive conditioning treatment followed by allogeneic stem cell transplantation with α/β T-cell and CD19+ B cell depleted donor stem cells.
1 baseline visit and multiple visits during transplantation and early recovery
Duration - Up to 1 year after transplantation
Participants will be followed for engraftment, chimerism, immune reconstitution, graft-versus-host disease (GVHD), and quality of life assessments.
Regular visits for monitoring during the 1-year follow-up period
Trial Site Locations
Total: 1 location
1
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
Research Team
M
Mitchell S Cairo, MD
L
Lauren Harrison, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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