Clinical trial · Interventional
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588
NCT04099966CI-TRIAL-00093347recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Amegakaryocytic Thrombocytopenia | — | UNRESOLVED | — |
| Beta-Thalassemia | — | UNRESOLVED | — |
| Diamond Blackfan Anemia | — | UNRESOLVED | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Kostmann | — | UNRESOLVED | — |
| Non-hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Severe Aplastic Anemia | — | UNRESOLVED | — |
| Sickle Cell Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpha beta depletion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- alpha beta cell depletion
- description
- Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.
- interventionNames
- Drug: alpha beta depletion
Primary outcomes (1)
- measure
- incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
- timeFrame
- 1 year
- description
- patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Secondary outcomes (2)
- measure
- incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 30 Years
Show eligibility criteria text
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 \<Grade 2 GVHD.
References
Publications (0)
Data not yet available
No reference posted for this study.