Using blinatumomab with autologous stem cell transplant for B-cell leukemia treatment
Safety and Efficacy of Blinatumomab and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia
This study is testing a new treatment for adults with B-cell leukemia that combines a drug called blinatumomab with a stem cell transplant to see if it helps improve their chances of recovery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | blinatumomab, chemotherapy, methotrexate |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06507514 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 15-65 with B-ALL who either lack a suitable allogeneic donor or refuse allogeneic HSCT.
Not a fit: Patients with isolated extramedullary lesions or those previously treated with anti-CD19 therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve leukemia-free survival and overall survival rates for patients with B-ALL.
How similar studies have performed: While the combination of blinatumomab and auto-HSCT is a novel approach, previous studies have shown the efficacy of blinatumomab in clearing MRD.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Suzhou, Jiangsu
- The First Affliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.