Clinical trial · Interventional
Immunotargeted Therapy Plus Low-Dose Chemotherapy in Newly Diagnosed Adult Ph+ B-ALL
A Prospective, Umbrella, Phase 2 Study of Immunotargeted Agents Combined With Low-Dose Chemotherapy in Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive B-Cell Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL). As an umbrella trial, all patients share the same target disease (newly diagnosed Ph+ B-ALL) and receive a uniform induction backbone consisting of multi-targeted immunotherapy, targeted therapy, and reduced-intensity chemotherapy. After induction, patients are stratified and assigned to two distinct consolidation pathways based on clinical condition, performance status, resource availability, and patient preference: Pathway A: Consolidation with CD19-directed CAR-T cell therapy to achieve deep molecular remission; Pathway B: Consolidation with sequential immunochemotherapy to maximize minimal residual disease (MRD) clearance. A backup chemotherapy backbone is provided for patients ineligible for antibody therapy. All patients, regardless of consolidation pathway, proceed to a unified long-term maintenance regimen. The primary endpoint is the complete molecular remission (CMR) rate after one cycle of induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated per NCI CTCAE version 5.0.
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+ Acute Lymphoblastic Leukemia (Ph+ALL) | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab | Drug | Blinatumomab | ALIAS |
| CD19-directed chimeric antigen receptor (CAR-T) T cells | Biological | — | UNRESOLVED |
| Inotuzumab Ozogamicin (IO) | Drug | Inotuzumab Ozogamicin | ALIAS |
| olverembatinib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Immunotargeted Therapy + Low-Dose Chemotherapy Arm
- description
- All patients receive a uniform induction therapy backbone combining targeted therapy, immunotherapy, and reduced-intensity chemotherapy. After induction, patients are stratified into two consolidation pathways based on clinical status: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to a unified long-term maintenance regimen.
- interventionNames
- Drug: olverembatinib
- Drug: Venetoclax
- Drug: Inotuzumab Ozogamicin (IO)
- Drug: Blinatumomab
- Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells
Primary outcomes (1)
- measure
- Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy
- timeFrame
- At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)
- description
- The proportion of patients achieving complete molecular remission (CMR), defined as undetectable BCR::ABL1 transcript by quantitative PCR (BCR::ABL1/ABL1 ratio \< 0.001%), after 1 cycle of induction therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Newly diagnosed, previously untreated Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) confirmed by cytogenetics and/or molecular testing * Leukemic blasts expressing CD22 * Adequate organ function (renal, hepatic, cardiac) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Life expectancy ≥ 3 months * Written informed consent obtained prior to any study-related procedures Exclusion Criteria: * Prior systemic anti-leukemic therapy, including chemotherapy, targeted therapy, or immunotherapy * History of chronic myeloid leukemia (CML) or other hematologic malignancies * Central nervous system (CNS) leukemia or extramedullary disease at diagnosis * Uncontrolled active infection or severe comorbidities * HIV positivity or known hepatitis B/C infection with active viral replication * Pregnant or breastfeeding * Inability to comply with study procedures or follow-up requirements
References
Publications (0)
Data not yet available