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 (Jun 2026). This Phase 2 trial studies BITE and DLI for leukemia.
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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07105579 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior organ transplantation disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 65 years or younger and at least 14 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify