Description:
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.
Title
- Brief Title: AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
- 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
Clinical Trial IDs
- ORG STUDY ID:
NYMC 588
- NCT ID:
NCT04099966
Conditions
- Acute Leukemia
- Severe Aplastic Anemia
- Non-hodgkin Lymphoma
- Hodgkin Lymphoma
- Kostmann
- Diamond Blackfan Anemia
- Amegakaryocytic Thrombocytopenia
- Sickle Cell Disease
- Beta-Thalassemia
Interventions
Drug | Synonyms | Arms |
---|
alpha beta depletion | α/β CD3+/CD19+ cell depletion | alpha beta cell depletion |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
alpha beta cell depletion | Experimental | 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. | |
Eligibility 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 <Grade 2 GVHD.
Maximum Eligible Age: | 30 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells |
Time Frame: | 1 year |
Safety Issue: | |
Description: | patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells |
Secondary Outcome Measures
Measure: | incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion |
Time Frame: | 1 year |
Safety Issue: | |
Description: | patients will have routine chimerism performed to monitoring engraftment of donor cells |
Measure: | incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion |
Time Frame: | 1 year |
Safety Issue: | |
Description: | patients will be monitored post transplant for signs of acute and chronic GVHD |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Mitchell Cairo |
Trial Keywords
- allogeneic stem cell transplantation
- t-cell depletion
- alpha beta cell depletion
Last Updated
February 27, 2020