OncoMatch/Clinical Trials/NCT05800210
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
Is NCT05800210 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Miltenyi CliniMACS Prodigy ® system for acute lymphoblastic leukemia.
Treatment: Miltenyi CliniMACS Prodigy ® system — This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myeloid Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: CBL mutation
JMML in CR1 without CBL mutation
Allowed: FLT3 mutation/duplication
FLT3 mutation/duplication (AML poor cytogenetics)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: unless being done as a boost
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender
Liver function
SGOT (AST) or SGPT (ALT) < 5 x ULN for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA)
Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as: Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 60% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender. Cardiac: Shortening fraction of ≥ 27% by echocardiogram) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA). Hepatic: SGOT (AST) or SGPT (ALT) < 5 x upper limit of normal (ULN) for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
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