NCT07840976Not yet recruitingPhase 2
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 · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 12 Oct 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT07840976
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 22
- From 12 Oct 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-leukemic therapy, including chemotherapy, targeted therapy, or immunotherapy
Other illness
- 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
Other
- Pregnant or breastfeeding
- Inability to comply with study procedures or follow-up requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.