Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation (IDE 13641) Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study
Medical College of Wisconsin
Summary
This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.
Description
This trial evaluates the ability of a biologically active therapy in blinatumomab, an anti-CD19/CD3 bispecific T-cell engager, to further reduce the risk of leukemia relapse following HCT to improve post-HCT outcomes. The investigators will also utilize an alpha-beta T-cell and B-cell depleted graft to reduce the risk of GVHD along with a reduced intensity conditioning regimen without the use of TBI in patients who are minimal residual disease (MRD) negative using high throughput sequencing (HTS) prior to HCT. For those patients who remain HTS-MRD positive, a myeloablative conditioning regimen…
Eligibility
- Age range
- Up to 25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of B-ALL with no evidence of minimal residual disease in the bone marrow by multi-parameter flow cytometry (FC-MRD negative, \<0.01%) and meet at least one of the following: 1. In remission after first relapse or greater (≥ CR2) 2. Very-high risk biology ALL that is proceeding to HCT in first remission (e.g. Induction failure, Severe-hypodiploidy, Ph-like ALL) 3. First remission with persistent disease identified as end of consolidation (EOC) MRD \> 0.01%. * Patients must have an available unrelated or haploidentical donor * Age ≤ 25 years at time of stu…
Interventions
- DeviceAlpha/Beta T-cell and B-cell depleted HCT
Device: Alpha/Beta T-cell and B-cell depletion
- DrugBlinatumomab
28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD
Location
- Children's Hospital of WisconsinMilwaukee, Wisconsin