Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL

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 inductio

Trial Details

NCT ID
NCT07493161
Phase
NA
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Olverembatinib
  • Venetoclax
  • Blinatumomab
  • Chemotherapy Backbone Regimens
  • Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
  • Inotuzumab ozogamicin
Locations (sample)
  • Tianjin, Tianjin Municipality, China|39.14222,117.17667

Key Eligibility Criteria

  • 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 UL…

For full eligibility, visit ClinicalTrials.gov.

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