Health TrialsbyHealthPanel

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

ConditionsLeukemiaAcute Myeloid Leukemia in RemissionMyelodysplasiaAcute Lymphoblastic Leukemia in RemissionChronic Myelogenous Leukemia - Chronic PhaseChronic Myelogenous Leukemia, Accelerated PhaseChronic Myelogenous Leukemia With Crisis of Blast CellsBiphenotypic Acute LeukemiaLymphoblastic LymphomaBurkitt LymphomaBurkitt LeukemiaLymphoma After RelapseOther Malignant Hematologic Diseases in Remission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-25
SponsorMedical College of Wisconsin

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Alpha/Beta T cell depletion (TCD) plus CD19+ depletionExperimental treatment 1 intervention

Trial outcomes

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

Time frame
1 year

Secondary outcomes

1

Evaluate incidence of chronic GVHD

Time frame
5 years
2

Evaluate time to platelet engraftment

Time frame
1 years
3

Assess incidence of viral infections

Time frame
2 years
4

Evaluate incidence of relapse/progressive disease

Time frame
2 years

Other outcomes

1

Assess tempo of CD4+ T cell reconstitution.

Time frame
2 years
2

Assess tempo of immune reconstitution.

Time frame
2 years
3

Assess ATG exposure using pre- and post- HCT AUC estimates using ATG dosing module

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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