Blinatumomab plus low-dose donor cells after transplant for high-risk B-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-center, prospective, single-arm Phase I trial in adults under 70 with high-risk B-ALL who have recently undergone allogeneic stem cell transplantation. Participants receive a maintenance regimen of blinatumomab followed by low-dose donor lymphocyte infusions at set intervals within the first year post-transplant, with dexamethasone premedication before each cycle. The study aims to assess safety and preliminary efficacy, including disease control and survival trends, in a structured, closely monitored setting. Enrollment criteria require MRD-negative status post-transplant, adequate organ function, and performance status suitable for maintenance therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures.

  2\) Age: \<70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:
  * \>CR1 status
  * Pre-transplant MRD+ status
  * Ph-like subtype
  * KMT2A rearrangement
  * Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.

    8\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.

    10\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).

Exclusion Criteria:

* 1\) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s).

  2\) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD).

  4\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.

  5\) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders.

  6\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.

  7\) Organ dysfunction:
* Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN
* Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Lu Wang
• Email: wangludophine@163.com
• Phone: 86-10-66937079

Similar studies

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

• 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

• MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

  This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.

  Recruiting at 30 sites Phase 2/3 Merck Sharp & Dohme LLC · Toronto, Ontario and 29 other locations · NCT07570173

• Universal CAR‑T (CT1190B) for CD19 and/or CD20 positive relapsed/refractory B‑cell acute lymphoblastic leukemia in patients aged 12–75

  This trial will test whether an off‑the‑shelf CAR‑T product (CT1190B) is safe and can induce remission in CD19 and/or CD20 positive relapsed or refractory B‑cell acute lymphoblastic leukemia for patients aged 12–75.

  Recruiting Early Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07470073

• Vaccine protection after blinatumomab in children with B-ALL

  This project will see if children and young adults (ages 1–21) with B-cell acute lymphoblastic leukemia who received blinatumomab keep protective immunity from routine childhood vaccines and whether revaccination restores immunity when levels are low.

  Recruiting at 2 sites Arkansas Children's Hospital Research Institute · Little Rock, Arkansas and 1 other locations · NCT07422337

• Asciminib in children and young adults with relapsed or refractory Ph+ or ABL-class Ph-like ALL

  This study tests asciminib in kids and young adults with relapsed or refractory Philadelphia-positive or ABL-class Ph-like ALL to see if it is safe and helps treat the leukemia.

  Recruiting at 4 sites Phase 1/2 Novartis · Sydney, New South Wales and 3 other locations · NCT07387926

• Sulforaphane to speed blood‑cell recovery after long‑frozen cord‑blood transplant

  This trial tries sulforaphane to see if it helps adults with high‑risk AML, ALL, or MDS recover blood cells faster after receiving cord blood units frozen for 10 years or more.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjing · NCT07297576

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.