Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL

Recruiting now · Not applicable

Conditions studied: Ph+ ALL

In brief

This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction/consolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab-based regimens. The primary endpoint for the venetoclax part is the rate of BCR-ABL \< 0.01% at day 90. The primary endpoint for the InO consolidation part is modified event-free survival (EFS) from the start of InO treatment. Key secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of molecular and hematologic relapse, NGS MRD negativity rates, and safety profiles including cardiovascular events and SOS/VOD. The study aims to enroll 110 patients in the initial phase and an additional 78 patients for the InO consolidation phase.

Key facts

Study ID: NCT07493161
Run by: Institute of Hematology & Blood Diseases Hospital, China
People needed: 110
Starts: 2026-04-10
Expected to finish: 2030-03-30
Last updated by the study team: 2026-07-23

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
Uncontrolled active severe infection.
Active psychiatric illness that may hinder treatment completion or informed consent.
Any other condition deemed unsuitable for the study by the investigator.

Where it is running

Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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