Using blinatumomab with autologous stem cell transplant for B-cell leukemia treatment

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 clinical trial investigates a new treatment strategy for adult patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) by combining blinatumomab with autologous hematopoietic stem cell transplantation (auto-HSCT). Patients will first receive induction and consolidation chemotherapy, followed by treatment with blinatumomab to clear minimal residual disease (MRD). After successful stem cell collection, patients will undergo auto-HSCT, with additional maintenance treatment using blinatumomab for up to a year. The study aims to evaluate the safety and efficacy of this approach over a two-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.
* positive expression of CD19 in peripheral blood or bone marrow primary cells detected by flow cytometry.
* ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation.
* subjects aged 15-65 years (including 15 and 65 years), regardless of gender.
* T-cell amplification test pass.
* expected survival \> 3 months.

Exclusion Criteria:

* patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.
* previously treated with anti-CD19 therapies.
* immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.
* uncontrolled active infections.
* HIV infection.
* active hepatitis B or hepatitis C infection.
* history of severe tachyphylaxis to aminoglycoside antibiotics.
* history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

Where it's running

• The First Affliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Similar studies

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

• 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

• 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

• Using decitabine, venetoclax, and blinatumomab for maintenance therapy in B-ALL patients after stem cell transplant

  This study is testing a combination of three medications to see if they can help people with B-cell acute lymphoblastic leukemia stay in remission after a stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06393985

• Blinatumomab treatment after specific stem cell transplant for high-risk leukemia

  This study is testing if a new treatment using blinatumomab after a special type of stem cell transplant can help children and young adults with high-risk leukemia stay in remission and live longer.

  Recruiting Phase 2 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT04746209

• Combination treatment for BCR-ABL positive B-cell leukemia and chronic myeloid leukemia

  This study is testing a new combination treatment for people with BCR-ABL positive B-cell leukemia or chronic myeloid leukemia to see if it helps them feel better and works well with existing medications.

  Recruiting at 4 sites Phase 1 Dana-Farber Cancer Institute · Chicago, Illinois and 3 other locations · NCT03595917

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

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.