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NCT04099966 | RECRUITING | Acute Leukemia

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

Mitchell Cairo

Information provided by (Responsible Party):

Mitchell Cairo

Brief 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.

Condition or disease

Acute Leukemia

Severe Aplastic Anemia

Non-hodgkin Lymphoma

Hodgkin Lymphoma

Kostmann

Diamond Blackfan Anemia

Amegakaryocytic Thrombocytopenia

Sickle Cell Disease

Beta-Thalassemia

Intervention/treatment

alpha beta depletion

Phase

PHASE2

Detailed Description:

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
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
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 : 2021-04-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Day to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 \
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

Location Details

NCT04099966

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

New York Medical College

Valhalla, New York, United States, 10595