Actively Recruiting

Phase 2
Age: 15Years +
All Genders
NCT06985485

Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-03-24

26

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a non-blinded, single-center, open-label, single-arm clinical study to evaluate a full-course immunotherapy regimen in patients with B-cell acute lymphoblastic leukemia (B-ALL). The study population includes newly diagnosed patients who are unfit for or decline intensive chemotherapy, as well as patients with relapsed/refractory disease or with measurable residual disease (MRD) positivity following prior chemotherapy. The trial aims to explore the efficacy and safety of sequential therapy with a CD19-directed CD3 T-cell engager and inotuzumab ozogamicin. The primary endpoint is overall survival (OS), while secondary endpoints include complete remission rate (CRR)、Objective Response Rate (ORR)、Event-free survival (EFS)、Relapse-free survival (RFS)、Cumulative incidence of relapse (CIR)、Non-relapse mortality (NRM) and safety.

CONDITIONS

Official Title

Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged 60 years or older
  • Newly diagnosed B-ALL patients aged 15 to under 60 years who are unfit for intensive chemotherapy due to factors such as poor performance status, severe cardiac, pulmonary, renal, or hepatic comorbidities, active infection, cognitive impairment, or other contraindications
  • Newly diagnosed B-ALL patients aged 15 to under 60 years who decline intensive chemotherapy for personal reasons such as fear of toxicity or quality of life preferences
  • Patients aged 15 years or older with relapsed/refractory B-ALL or measurable residual disease positivity after prior chemotherapy
  • Left ventricular ejection fraction of 40% or higher
  • Creatinine clearance of 30 mL/min or higher
  • ALT and AST levels no more than 3 times the upper limit of normal, total bilirubin no more than 2 times the upper limit of normal unless due to leukemia
  • Grade 1 or less dyspnea and oxygen saturation above 91% without supplemental oxygen
  • Ability to understand and voluntarily sign the informed consent form
  • Life expectancy of 3 months or more
Not Eligible

You will not qualify if you...

  • Presence of central nervous system or other extramedullary disease
  • Other active cancers requiring treatment
  • Prior treatment with CD19- or CD22-targeted therapies including blinatumomab, inotuzumab ozogamicin, or CAR-T therapy
  • Use of immunosuppressive drugs within 2 weeks before consent or planned long-term immunosuppressive therapy
  • Active severe cardiac disease classified as NYHA Class 3 or higher
  • Severe chronic liver disease such as cirrhosis or active hepatitis
  • Occult or prior hepatitis B infection with detectable HBV DNA without antiviral prophylaxis
  • Positive hepatitis C antibody with detectable HCV RNA
  • History of severe or persistent veno-occlusive disease or sinusoidal obstruction syndrome
  • Uncontrolled bacterial, fungal, viral, mycoplasma, or other infections
  • Past or current central nervous system disorders like seizures, stroke, dementia, or autoimmune diseases
  • Primary immunodeficiency or active autoimmune disease
  • History of severe allergic reactions to study drugs
  • Receipt of live vaccines within 6 weeks before screening
  • Psychiatric or other conditions that may affect study compliance
  • Pregnant or breastfeeding women or those unwilling to use contraception
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

S

Sheng-Li Xue, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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