Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 2
Age: 0 - 25Years
All Genders
ID04746209
Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study
Led by Medical College of Wisconsin · Updated on 2021-09-17
25
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for children, adolescents, and young adults up to 25 years old with high-risk B-cell acute lymphoblastic leukemia (B-ALL). This study aims to reduce leukemia relapse and improve survival after hematopoietic cell transplantation (HCT) by using a special type of transplant combined with the drug blinatumomab. The study also seeks to lower treatment-related complications and late effects, adjusting pre-transplant conditioning based on minimal residual disease (MRD) status using high throughput sequencing. Participants receive an alpha-beta T-cell and B-cell depleted transplant. Those who test positive for MRD by sequencing but negative by flow cytometry undergo a myeloablative conditioning regimen including total body irradiation (TBI), followed by the transplant and a 28-day continuous blinatumomab infusion starting 100 days after transplant if no significant graft-versus-host disease (GVHD) is present. Participants who are MRD negative by both methods receive a reduced intensity conditioning regimen before the same type of transplant and post-transplant blinatumomab infusion under similar conditions. Throughout the study, participants will be monitored for their ability to receive blinatumomab, treatment-related side effects, survival, disease relapse, graft success or failure, GVHD occurrence, and patient-reported outcomes. Assessments include clinical exams, laboratory tests, and minimal residual disease measurements at multiple points up to one year after transplantation. The total planned enrollment is approximately 25 patients, with follow-up lasting at least one year post-transplant.
CONDITIONS
Brief Title
Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT
Who Can Participate
Age: 0 - 25Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of B-ALL with no minimal residual disease detected by flow cytometry (<0.01%) and either in remission after first relapse or greater, very-high risk biology ALL proceeding to transplant in first remission, or first remission with persistent disease at end of consolidation
- Available unrelated or haploidentical donor
- Age 25 years or younger at enrollment
- Karnofsky Performance Status 60% or higher (if 16 years or older) or Lansky Play Score 60 or higher (if under 16 years)
- Acceptable organ function within 14 days before enrollment including renal, liver, heart, lung, and central nervous system as specified
- No active graft-versus-host disease and off transplant immune suppression for at least 7 days if relapse occurred after transplant
- At least 42 days since any immunotherapy other than blinatumomab
- No cranial or craniospinal radiation during protocol therapy; at least 90 days since prior TBI or related radiation
- Agreement to use contraception during treatment and for 2 months after blinatumomab therapy if sexually active and of childbearing potential
- Voluntary written consent prior to study procedures
- Enrollment in the Blinatumomab Bridging Therapy Trial
You will not qualify if you...
- Active extramedullary or chloromatous disease
- Receiving other chemotherapy, radiation, immunotherapy, or anti-cancer therapy not specified in the protocol
- Uncontrolled systemic infections including fungal, bacterial, or viral infections
- Pregnant or breastfeeding females
- Known allergy to any chemotherapy or targeted agents in the protocol
- Participation in another Phase 1 or 2 study for disease treatment
- Active cancers other than B-ALL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day 0 (transplant day)
Participants undergo alpha/beta T-cell and B-cell depleted hematopoietic cell transplantation (HCT) with either myeloablative or reduced intensity conditioning depending on minimal residual disease status.
1 transplant visit
Treatment
Duration - 28 days starting Day 100 post-HCT
Starting on Day 100 post-transplant, participants receive a 28-day continuous infusion of blinatumomab if no significant ongoing graft-versus-host disease (GVHD) is present.
1 continuous infusion period beginning Day 100 post-transplant
Follow-up
Duration - Up to 1 year post-HCT
Participants are monitored for treatment-related adverse events, graft function, disease status, graft-versus-host disease, and survival outcomes up to 1 year post-transplant.
Visits at Day +28, +100, +180, and 1 year post-transplant
Trial Site Locations
Total: 1 location
1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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Research Team
M
Meredith Beversdorf, RN
E
Emily Ruszkiewicz, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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