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.

NCT06649422 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Shandong University
Status	NOT_YET_RECRUITING
Enrolment	36
Start date	2024-11-01
Completion	2027-12

Conditions

• Leukemia, Lymphocytic, Acute, Adult

Interventions

• Blinatumomab

Primary outcomes

• The overall response rate — At the end of induction treatment from day 28 to day 35
  The overall response rate after induction therapy = Complete Remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (Cri).
• Minimal Residual Disease (MRD) negativity rate after induction therapy — At the end of induction treatment from day 28 to day 35
  MRD negativity refers to a flow cytometry test result where MRD is less than 0.01%.