Clinical trial · Interventional
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ph+ ALL | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) | Other | — | UNRESOLVED |
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| Chemotherapy Backbone Regimens | Drug | — | UNRESOLVED |
| Inotuzumab ozogamicin | Drug | Inotuzumab Ozogamicin | ALIAS |
| Olverembatinib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy (Chemotherapy + Olverembatinib)
- description
- 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 for 2 years. OVB maintenance therapy continues for at least 5 years. Optional Add-on 1: Patients may receive 1-4 cycles of blinatumomab starting from Cycle 4. Optional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4 Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment.
- interventionNames
- Drug: Olverembatinib
- Drug: Blinatumomab
- Drug: Chemotherapy Backbone Regimens
- Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
- Drug: Inotuzumab ozogamicin
- type
- EXPERIMENTAL
- label
- Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
Inclusion 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 ULN; Left ventricular ejection fraction (LVEF) \>45%. * Male and female patients of childbearing potential must agree to use effective contraception. * Signed informed consent. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available