NCT06649422

Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study

Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.

Detailed description

The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia. On day 14, an intrathecal injection of chemotherapy is administered; on days 28-35, bone marrow is assessed, and patients who do not achieve complete remission are withdrawn from the study. Patients with positive minimal residual disease (MRD) after induction treatment undergo transplant typing and proceed to allogeneic hematopoietic stem cell transplantation (Allo-HSCT) after early intensification. Patients with negative MRD receive alternating treatment with multi-drug combination chemotherapy and blinatumomab, for a total of 8 consolidation courses, including 3 courses of blinatumomab. Maintenance therapy lasts for at least 18 months, using the POMP regimen with or without one cycle of blinatumomab every six months. Throughout the entire treatment phase, at least 12 preventive intrathecal injections are administered.

Conditions

• Leukemia, Lymphocytic, Acute, Adult

Interventions

Type	Name	Description
DRUG	Blinatumomab	The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2024-10-18
• Last updated: 2024-10-18