Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). The researchers are testing a combination of a medication called blinatumomab and autologous stem cell transplantation (auto-HSCT) to see if this "sandwich" strategy can help improve the chances of staying free from leukemia and increase overall survival. The goal is to find out if this method is safe and effective for patients who either don’t have a suitable donor for another type of stem cell transplant or choose not to go that route.

To participate in the trial, individuals need to be between 15 and 65 years old, have a confirmed diagnosis of B-ALL, and meet certain health criteria, such as having adequate heart and lung function. Participants can expect to undergo treatment with blinatumomab followed by auto-HSCT, and the study will closely monitor their health to assess the treatment's effects. It's important for potential participants to discuss their full medical history with the study team, as some pre-existing conditions or recent treatments could affect eligibility.

Gender

ALL

Eligibility 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.