MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05794880
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Biphenotypic Acute Leukemia
  • Burkitt Leukemia
  • Burkitt Lymphoma
  • Chronic Myelogenous Leukemia - Chronic Phase
  • Chronic Myelogenous Leukemia With Crisis of Blast Cells
  • Chronic Myelogenous Leukemia, Accelerated Phase
  • Leukemia
  • Lymphoblastic Lymphoma
  • Lymphoma After Relapse
  • Myelodysplasia
  • Other Malignant Hematologic Diseases in Remission

Eligibility Criteria

Sex
ALL
Age
0 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) — DEVICE
    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.

Study Details

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

Key Dates

Start date
May 1, 2023
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alpha/Beta T cell depletion (TCD) plus CD19+ depletion
    Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies

Primary Outcome Measure

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 [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's WisconsinMilwaukeeWisconsin53226
Meredith Beversdorf, RN
[email protected]
414-266-5891
Amy Moskop (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milwaukee, WI

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Children's Wisconsin· Milwaukee, WI

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