Immune and targeted drugs with low-dose chemotherapy for new Ph+ acute lymphoblastic leukemia
Tests combined immune, targeted and low-dose chemotherapy drugs in adults newly diagnosed with Ph+ ALL.
Plain-language title generated from the registry record
Registry title: Immunotargeted Therapy Plus Low-Dose Chemotherapy in Newly Diagnosed Adult Ph+ B-ALL
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Where in China
- Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)Tianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT07840976
- Record updated
- 25 September 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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: 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.