Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo rozpoznana białaczka ALL z chromosomem Philadelphia
- •Wiek co najmniej 14 lat
- •Wystarczająco dobra funkcja narządów (wątroba, nerki, serce)
- •Dobrze funkcjonujący układ sercowo-naczyniowy (frakcja wyrzutu lewej komory powyżej 45%)
- •Pacjenci w wieku rozrodczym muszą przyjąć stosowanie skutecznej antykoncepcji
- •Podpisana świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Rozpoznana przewlekła białaczka szpikowa (CML) w fazie zaawansowanej
- •Wcześniejsze leczenie chemioterapią (poza sterydami lub hydroksyureą)
- •Zawał serca w ciągu ostatnich 12 miesięcy lub niestabilna choroba serca
- •Niekontrolowana ciężka infekcja
- •Aktywne zaburzenia psychiatryczne mogące uniemożliwić ukończenie leczenia
- •Inne warunki uznane przez lekarza za niezgodne z badaniem
Simplified criteria — AI translation
Trial details
- Minimum age
- 14 Years
- Last updated (source)
- July 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Blood Diseases Hospital
Tianjin, China
Trial contact
Hui Wei, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/24/2026.
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