A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL

PHASE2RecruitingINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 1, 2028

Conditions
Acute Lymphoblastic LeukemiaPhiladelphia ChromosomePhiladelphia-Positive ALLAdult ALLIKZF1 Gene Mutation
Interventions
DRUG

Prednisone, Olverembatinib, Blinatumomab, Chidamide

"Phase One. Induction Consolidation, for 1 year. 1.1 Pretreatment ×1 cycle. Prednisone,1mg/kg/d, from day 1 to 14;~1.2 Induction Therapy × 1 cycle. A: OlverembAtinib (at a dose of 40 mg Qod), from day 8 to 42. B: Blinatumomab (at a dose of 28 μg per day), from day 15 to 28. C: Chidamide (at a dose of 10 mg Qod), from day 9 to 41.~1.3 Consolidation Block × 5 cycles. A: Olverembatinib (at a dose of 40 mg Qod) was administered from day 1 to 42. B: Blinatumomab (at a dose of 28 μg perday) was administered from day 1 to 14. C: Chidamide (at a dose of 10 mg Qod) was administered from day 14 to 41.~Phase Two. Maintenance Therapy, for 3 years. 2.1 A: Olverembatinib (at a dose of 40 mg Qod) was administered from day 1 to 42.~C: Chidamide (at a dose of 10 mg Qod) was administered from day 14 to 41.~Phase Three. Follow-up, for 5 years."

Trial Locations (1)

510515

RECRUITING

Dept of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER