CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS… (NCT04151706) | Clinical Trial Compass
CompletedPhase 2
CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML
United States7 participantsStarted 2020-02-27
Plain-language summary
This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
Who can participate
Age range18 Years – 65 Years
SexALL
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Recipient Inclusion Criteria:
* Acute leukemia, in morphologic complete remission, OR myelodysplasia with \< 10% blasts in the marrow, and no circulating blasts that contain auer rods. Patients with chronic myelomonocytic leukemia (CMML) must have a WBC count ≤ 10,000 cells/μL and \< 10% blasts in the marrow.
* Planned myeloablative conditioning regimen at Stanford University Medical Center.
* Karnofsky or Lansky Performance Score ≥ 70%.
* Must have an HLA related donor as follows: onor must be an 8/8 match for HLA A, B and C at intermediate (or higher) resolution, and DRB1 at high resolution using DNA based typing. The donors must be willing to receive G CSF followed by collection of cells by apheresis, and must meet the Program's criteria for donation.
* Cardiac function: Ejection fraction at rest ≥ 40%.
* Serum creatinine value of \< 1.5 mg/dL, or an estimated creatinine clearance greater than 50 mL/minute (using the Stanford calculator for eGFR available in EPIC)
* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% (adjusted for Hgb)
* Forced vital capacity (FVC) ≥ 50%.
* Forced expiratory volume (FEV1) ≥ 50%.
* Total bilirubin \< 2 times the upper limit of normal (ULN) (unless the elevated bilirubin is attributed to Gilbert's Syndrome)
* Alanine aminotransferase (ALT) \< 2.5 x ULN
* Aspartate aminotransferase (AST) \< 2.5 x ULN
* Total bilirubin \< 2 times the upper limit of normal (unless elevated bilirubin is attributed to Gilbert's Syndrome)
* Signed in…
What they're measuring
1
Number of Participants Achieving Graft-versus-Host Disease-Free and Relapse-Free Survival (GRFS) Through 1 Year Post-Transplant