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OncoMatch/Clinical Trials/NCT04746209

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Is NCT04746209 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Alpha/Beta T-cell and B-cell depleted HCT and Blinatumomab for b-cell acute lymphoblastic leukemia.

Phase 2RecruitingMedical College of WisconsinNCT04746209Data as of May 2026

Treatment: Alpha/Beta T-cell and B-cell depleted HCT · BlinatumomabThis trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Prior therapy

Must have received: hematopoietic cell transplant

Patients must have an available unrelated or haploidentical donor

Cannot have received: immunotherapy (blinatumomab)

Exception: allowed if at least 42 days after completion

At least 42 days after the completion of any type of immunotherapy aside from blinatumomab (e.g. tumor vaccines or CAR T-cell therapy).

Cannot have received: radiation therapy

Exception: ≥ 90 days must have elapsed if prior TBI, cranial or craniospinal XRT

Cranial or craniospinal XRT is prohibited during protocol therapy. ≥ 90 days must have elapsed if prior TBI, cranial or craniospinal XRT

Lab requirements

Kidney function

creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73m2

Liver function

ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 3 mg/dL

Cardiac function

left ventricular ejection fraction ≥ 40% by ECHO/MUGA

Renal: creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73m2 Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 3 mg/dL Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA Pulmonary: No evidence of dyspnea at rest. No supplemental oxygen requirement. If measured, carbon monoxide diffusion capacity (DLCO) > 50%. Central Nervous System: Based on clinical exam, no concern for/evidence of active CNS infection. Patients with fully treated prior CNS infections are eligible. Patients with seizure disorders may be enrolled if seizures are well-controlled on anticonvulsant therapy.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital of Wisconsin · Milwaukee, Wisconsin

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