Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion – NYMC 588

Study point of contact

Lauren Harrison, RN
6172857844
[email protected]
Mitchell S Cairo, MD
9145942150
[email protected]

Locations

1 United States site

Age

< 30 Years

Genotypes

SC

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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.

participation requirements

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

participation restrictions

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

Locations

  • Valhalla, New York, United States, New York Medical College, 10595