OncoMatch/Clinical Trials/NCT07105579

Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia

Is NCT07105579 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies BITE and DLI for leukemia.

Phase 2RecruitingFirst Affiliated Hospital of Zhejiang UniversityNCT07105579Data as of May 2026

Treatment: BITE and DLI — A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD19 expression (any)

CD19 expression on leukemic cells (regardless of CD19 positivity rate)

Required: ABL1 wild-type

Ph-negative B-ALL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: allogeneic hematopoietic stem cell transplant

≥2 months post-transplant with hematopoietic reconstitution

Cannot have received: organ transplantation

Exception: excluding hematopoietic stem cell transplantation

Prior organ transplantation (excluding hematopoietic stem cell transplantation)

Lab requirements

Kidney function

Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min; exclusion: serum creatinine >2× ULN or 24-hour creatinine clearance <50 mL/min

Liver function

AST and ALT ≤3× ULN, total bilirubin ≤2×ULN; exclusion: ALT or total bilirubin >3× ULN

Cardiac function

Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO); exclusion: LVEF <60%, clinically significant arrhythmias, prolonged QTc (men >450 ms; women >470 ms), MI within past year, symptomatic CAD requiring medication

Adequate organ function: AST and ALT ≤3× ULN, total bilirubin ≤2×ULN. Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault). LVEF ≥50% by ECHO. Exclusion: severe cardiac, pulmonary, hepatic, or renal impairment as defined.

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

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