MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing (NCT05794880) | Clinical Trial Compass
RecruitingNot Applicable
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing
United States40 participantsStarted 2023-05-01
Plain-language 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
Who can participate
Age range0 Years – 25 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient age \< 25 years. Both genders and all races eligible.
✓. Disease eligibility
✓. 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.
✓. Negative pregnancy test for patients capable of childbearing potential
✓. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.
Exclusion criteria
✕. 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
What they're measuring
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
✕. 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.