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Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study

Status: Recruiting

Location: See location...

Intervention Type: Other, Drug

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

This is a prospective, open-label, randomized controlled trial to evaluate the efficacy of low-intensity chemotherapy combined with venetoclax and blinatumomab in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Patients will be randomized to receive or not receive venetoclax during the first three cycles of induction and consolidation therapy. All patients receive olverembatinib (a third-generation TKI) continuously and may receive up to 4 cycles of blinatumomab starting from the fourth cycle. The primary endpoint is the rate of BCR::ABL1 ≤0.01% at 90 days and event-free survival (EFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), molecular relapse rate, MRD negativity rate by NGS, and cardiovascular events.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 14

Healthy Volunteers: f

View:

• Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).

• Age ≥ 14 years.

• ECOG performance status ≤ 2.

• Adequate organ function: Total bilirubin \<1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine \<2x ULN; Cardiac enzymes \<2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \>45%.

• Male and female patients of childbearing potential must agree to use effective contraception.

• Signed informed consent.

Locations

Other Locations

China

Blood Diseases Hospital

RECRUITING

Tianjin

Contact Information

Primary

Hui Wei, MD

weihui@ihcams.ac.cn

13132507161

Time Frame

Start Date: 2026-04-10

Estimated Completion Date: 2030-03-30

Participants

Target number of participants: 110

Treatments

Active_comparator: Standard Therapy (Chemotherapy + Olverembatinib)

Patients receive a backbone of low-intensity chemotherapy combined with olverembatinib(OVB) .~Induction : Vincristine D1,8,15,22; Prednisone D1-28; Olverembatinib D1-28；~Consolidation 1 \& 2: Olverembatinib D1-28; Prednisone D1-14；Vincristine D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.~Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age .~Maintenance therapy: MM and VP regimen with or without venetoclax according to the study groups for 2 years. OVB maintenance therapy continues for at least 5 years.~Optional Add-on: Patients may receive 1-4 cycles of blinatumomab starting after Consolidation 1.If the patient undergoes CAR-T therapy, the following conditioning regimen will be administered in cycle 4.~Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.

Experimental: Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax)

Patients receive the same backbone as the Control Arm plus the BCL2 inhibitor venetoclax for the first three treatment blocks.~Consolidation 1 \& 2 (OP, 4 weeks each): Olverembatinib (40mg every other day) D1-28; Prednisone D1-14；Vincristine (VCR) D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.~Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age.~Maintenance therapy:MM and VP regimen with or without venetoclax according to the study groups for 2 years. Olverembatinib therapy for at least 5 years.~Optional Add-on: Patients with financial means may receive 1-4 cycles of blinatumomab starting after Consolidation 1.If the patient undergoes CAR-T therapy, the following conditioning regimen will be administered in cycle 4.~Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.

Related Therapeutic Areas

Acute Lymphoblastic Leukemia (ALL)

Leukemia

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