MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing
Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable leukemia
Started May 2023
Longer than P75 for not_applicable leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2032
April 29, 2025
April 1, 2025
4 years
March 8, 2023
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
1 year
Secondary Outcomes (6)
Evaluate incidence of chronic GVHD
5 years
Evaluate time to platelet engraftment
1 years
Assess incidence of viral infections
2 years
Evaluate incidence of relapse/progressive disease
2 years
Evaluate incidence of treatment-related mortality (TRM).
2 years
- +1 more secondary outcomes
Other Outcomes (3)
Assess tempo of CD4+ T cell reconstitution.
2 years
Assess tempo of immune reconstitution.
2 years
Assess ATG exposure using pre- and post- HCT AUC estimates using ATG dosing module
1 year
Study Arms (1)
Alpha/Beta T cell depletion (TCD) plus CD19+ depletion
EXPERIMENTALAlpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies
Interventions
Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.
Eligibility Criteria
You may qualify if:
- Patient age \< 25 years. Both genders and all races eligible.
- Disease eligibility
- Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)
- Myelodysplasia
- Acute lymphoblastic leukemia - Disease status: MRD negative
- Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase
- Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative
- Lymphoblastic lymphoma - Disease status: in remission
- Burkitt's lymphoma/leukemia - Disease status: in remission
- Lymphoma after relapse - Disease status: in remission
- Other malignant hematologic diseases in remission (to be approved by PI)
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
- Evaluation of organ status as per MCW BMT SOP
- Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- Signed consent by parent/guardian or able to give consent if ≥18 years.
- +11 more criteria
You may not qualify if:
- Patients who do not meet disease, organ, or infectious criteria.
- No suitable donor
- Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
- Participating in a concomitant Phase 1 or 2 study involving treatment of disease
- Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 8, 2023
First Posted
April 3, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2032
Last Updated
April 29, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share