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Immunotargeted Therapy Plus Low-Dose Chemotherapy in Newly Diagnosed Adult Ph+ B-ALL

ConditionPh+ Acute Lymphoblastic Leukemia (Ph+ALL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • olverembatinib

    Drug

    Third-generation tyrosine kinase inhibitor (TKI) targeting BCR::ABL1, administered orally daily as part of induction, consolidation, and maintenance therapy.

  • Venetoclax

    Drug

    BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.

  • Inotuzumab Ozogamicin (IO)

    Drug

    Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.

  • Blinatumomab

    Drug

    CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.

  • CD19-directed chimeric antigen receptor (CAR-T) T cells

    Biological/Vaccine

    Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Immunotargeted Therapy + Low-Dose Chemotherapy ArmExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy

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.

Time frame
At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)

Secondary outcomes

1

3-Month Complete Remission (CR)

Time frame
3 months after study enrollment
2

3-Month MRD Negativity Rates

Time frame
3 months after study enrollment
3

2-Year Overall Survival (OS)

OS is defined as the time from study enrollment to death from any cause.

Time frame
2 years after the last patient enrollment
4

2-Year Disease-Free Survival (DFS)

DFS is defined as the time from study enrollment to disease relapse or death from any cause.

Time frame
2 years after the last patient enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: