Using Blinatumomab to prepare for stem cell transplant in high-risk leukemia

A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

This study is testing if the drug Blinatumomab can help people with high-risk leukemia get ready for a stem cell transplant and improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Blinatumomab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05559450 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of Blinatumomab as a treatment to bridge patients with high-risk precursor B-cell acute lymphoblastic leukemia (BCP-ALL) to allogeneic hematopoietic stem cell transplantation. Patients who are in hematologic remission and meet specific eligibility criteria will receive Blinatumomab alongside conventional therapy. The goal is to improve outcomes for patients with this aggressive form of leukemia, which typically has a poor prognosis.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with high-risk precursor B-ALL who are in hematologic remission and have an ECOG score of 0-2.

Not a fit: Patients with severe organ dysfunction, active infections, or those who have previously undergone stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the chances of successful stem cell transplantation and improve survival rates for patients with high-risk BCP-ALL.

How similar studies have performed: While this approach is being explored in this specific context, similar studies using Blinatumomab have shown promise in treating B-cell malignancies.

Eligibility criteria

Inclusion Criteria:

1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
2. ECOG score is 0-2.
3. Expecting life span is more than 6 months.
4. Patients are free from severe organ dysfunction.

Exclusion Criteria:

1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \>2.5mg/ dL or blood Creatinine clearance rate \< 30ml/min.
2. Patients are combined with infection or other complications that can not tolerate chemotherapy.
3. Patients are suffering from central nervous system/solitary extramedullary leukemia.
4. Patients are considered as tumer progression.
5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
6. Pregnant and lactating women will not be included.

Where this trial is running

Suzhou, Jiangsu

• The first affiliated hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Yue Han, MD/PhD — The First Affiliated Hospital of Soochow University
• Study coordinator: Huizhu Kang, MD

Conditions B-cell Acute Lymphoblastic Leukemia