Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell (NCT01660607) | Clinical Trial Compass
CompletedPhase 1/2
Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell
United States68 participantsStarted 2012-02-09
Plain-language summary
This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.
Who can participate
Age range13 Years – 73 Years
SexALL
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Inclusion criteria
✓. Patients with the following diseases that are histopathologically confirmed are eligible
✓. Age ≥18 yo and ≤ 60 yo for patients in Cohort 1 only. At the start of Cohort 2A and beyond, eligibility will be expanded to allow pediatric patients age ≥ 13 yo.
✓. Cardiac ejection fraction ≥ 45%
✓. Lung diffusion capacity ≥ 50%
✓. Calculated creatinine clearance ≥ 50 cc/min
✓. Serum glutamic-pyruvic transaminase( SGPT) and serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3.0 x ULN (Upper limit of normal), unless elevated secondary to disease.
✓. Total bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome may be included at the discretion of the PI or where hemolysis has been excluded
✓. Availability of a HLA matched donor (related or unrelated) defined by Class I (HLA-A and B) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular typing. An HLA matched donor is defined for this study to be a sibling that is HLA matched 6/6; or an unrelated donor that is HLA matched 6/6 or 5/6. A sibling may be a "half sibling."
Exclusion criteria
✕. Seropositive for any of the following:
✕. Prior myeloablative therapy or hematopoietic cell transplant