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Recruiting Phase 2

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

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About this 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.

Condition
Acute Leukemia, Severe Aplastic Anemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Kostmann, Diamond Blackfan Anemia, Amegakaryocytic Thrombocytopenia, Sickle Cell Disease, Beta-Thalassemia
Tested
alpha beta depletion
Sponsor
Mitchell Cairo

Who can join

Age
0 to 30 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 0 years
  • Maximum age: 30 years
  • Study condition: Acute Leukemia, Severe Aplastic Anemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Kostmann, Diamond Blackfan Anemia, Amegakaryocytic Thrombocytopenia, Sickle Cell Disease, Beta-Thalassemia
  • 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
  • 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 6

  • 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.

Where

1 site, 1 recruiting

New York Medical College

Valhalla, New York, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.