Overview

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

Status:
Not yet recruiting

Trial end date:
2024-12-31

Target enrollment:
0

Participant gender:
All

Summary

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mitchell Cairo

Criteria

Inclusion Criteria:

1. 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;

2. 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

3. 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

Exclusion Criteria:

1. Females who are pregnant or breast-feeding are not eligible.

2. Patients with documented uncontrolled infection at the time of study entry are not
eligible.

3. Karnofsky/Lansky (age appropriate) Performance Score <60

4. Demonstrated lack of compliance with medical care

5. Patients who have received allogeneic HSCT within 6 months, unless being done as a
boost.

6. Patients with active