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RecruitingPhase 2NCT06220487

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

A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

67 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic LeukemiaAdult ALLPhiladelphia-Positive ALLPhiladelphia ChromosomeIKZF1 Gene Mutation

Summary

ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3/CD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for Ph+ ALL. Investigatorsaim to explore the efficacy and safety of ABC regimen. The primary endpoint is the complete molecular remission （CMR） at 3 months, secondary endpoints are overall survival (OS), event-free survival (EFS), adverse event (AE), IKZF1del, IKZF1plus, IKZF1lpus/CD20 subgroup EFS/OS.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — olverembatinib (a BCR-ABL inhibitor), a CD3/CD19 bispecific antibody (a type of immunotherapy), and chidamide (an epigenetic drug) — in adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a form of blood cancer, who are not able to receive a stem cell transplant. **You may be eligible if...** - You are 18 or older with a new diagnosis of Ph+ ALL (B-precursor type) - You have not previously received systemic chemotherapy or CAR-T therapy for ALL - You are not eligible for a bone marrow/stem cell transplant - Your heart, kidney, liver, and pancreatic function are adequate - You test negative for HIV, hepatitis B, and hepatitis C **You may NOT be eligible if...** - You have a significant heart problem (weak heart, abnormal heart rhythm, long QT syndrome, recent heart attack) - Your leukemia has spread to the brain (CNS leukemia) - You have a gastrointestinal condition that affects how you absorb oral medications - You have an active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisone, 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.

Locations(1)

Dept of Hematology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT06220487

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