Blinatumomab plus donor lymphocyte infusion to prevent relapse after transplant in high-risk Ph-negative B‑cell ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑arm Phase 2 maintenance trial that gives post‑transplant blinatumomab combined with planned donor lymphocyte infusion (DLI) to patients with high‑risk Ph‑negative B‑cell ALL. Eligible participants are at least two months post–allo‑HSCT, in marrow remission and MRD‑negative before starting treatment, with adequate organ function and no active severe graft‑versus‑host disease. The trial will monitor safety (including cytopenias and GVHD) and relapse rates to determine whether the regimen reduces post‑transplant recurrence. Treatment tolerability will also be tracked to characterize adverse events and feasibility of this combined maintenance approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 14-65 years (inclusive), regardless of gender.
2. Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
3. Ph-negative B-ALL with high-risk features post-allo-HSCT .
4. ≥2 months post-transplant with hematopoietic reconstitution.
5. Bone marrow morphology in remission and MRD-negative before enrollment.
6. ECOG performance status \<3 and Karnofsky score ≥70.
7. No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
8. Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO).
9. Expected survival \>3 months.
10. Voluntary provision of written informed consent, with ability to understand and comply with study requirements.

Exclusion Criteria:

1. History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
2. Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
3. Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) \<60%.Clinically significant arrhythmias (e.g., ventricular tachycardia, atrial fibrillation, second-degree heart block).Prolonged QTc interval (men \>450 ms; women \>470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
4. Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
5. Severe hepatic impairment:ALT or total bilirubin (TBIL) \>3× upper limit of normal (ULN).
6. Severe renal impairment:Serum creatinine (Cr) \>2× ULN.24-hour creatinine clearance (Ccr) \<50 mL/min.
7. Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
8. History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
9. Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
10. Major organ surgery within the past six weeks.
11. Drug abuse or chronic alcoholism that may interfere with study assessments.
12. Prior organ transplantation (excluding hematopoietic stem cell transplantation).
13. Other conditions deemed by the investigator to make the patient unsuitable for participation.

Where it's running

• First Affiliated Hospital of Zhejiang University
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Yi Luo, MD
• Email: luoyijr@zju.edu.com
• Phone: 86-13666609126

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New treatment approach for pediatric patients with relapsed B-cell leukemia

  This study is testing a new combination treatment for kids with relapsed B-cell leukemia to see if it helps them get better and live longer.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT05645718

• Genetics of Blood Cancers in the U.S. population

  This study tests how genetic factors relate to blood cancers by collecting saliva DNA and online health surveys from at least 10,000 U.S. adults.

  Recruiting Rutgers, The State University of New Jersey · Piscataway, New Jersey · NCT07714044

• Blinatumomab plus low-dose donor cells after transplant for high-risk B-ALL

  This small, early-phase study tests whether giving blinatumomab with low-dose donor lymphocytes after allogeneic transplant is safe and helps long-term survival for people with high-risk B-ALL.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07677878

• Strength Training for Kids with Acute Lymphoblastic Leukemia and Lymphoblastic L lymphoma

  Researchers are testing a structured strength-training program for children and teens recently diagnosed with ALL or lymphoblastic lymphoma to see if it helps with weight gain and physical function during treatment.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07634653

• How facial type relates to relapse after orthodontic treatment during retention

  This study tests whether people with different facial types have different patterns of tooth movement relapse after orthodontic treatment during the retention phase.

  Recruiting Postgraduate Institute of Dental Sciences Rohtak · Rohtak, Haryana · NCT07622277

• LP-118 in combination with standard therapy for newly diagnosed Ph+ ALL

  This study tests whether adding LP-118 to the standard therapy for adults with Philadelphia chromosome–positive ALL is safe and useful.

  Recruiting at 2 sites Phase 1 Wake Forest University Health Sciences · Charlotte, North Carolina and 1 other locations · NCT07614022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.