Full-course immunotherapy for B‑cell acute lymphoblastic leukemia patients who are unfit for or decline chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center, open-label, single-arm study gives sequential CD19-directed CD3 T-cell engager therapy (blinatumomab) followed by inotuzumab ozogamicin to patients with B‑cell ALL who are newly diagnosed but unfit for or who decline intensive chemotherapy, as well as to those with relapsed/refractory disease or MRD positivity. The trial is non-blinded and enrolls patients at The First Affiliated Hospital of Soochow University. The primary endpoint is overall survival, and secondary endpoints include complete remission rate, objective response rate, event-free survival, relapse-free survival, cumulative incidence of relapse, non-relapse mortality, and safety. Safety monitoring and response assessments will follow standard hematologic oncology practice with serial bone marrow evaluations and clinical follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per NCCN guidelines.
2. Newly diagnosed B-ALL patients aged ≥15 to \<60 years who are unfit for intensive chemotherapy (Unfit), as per NCCN guidelines, meeting at least one of the following criteria:

1、ECOG score ≥2 2、Severe cardiac comorbidities (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction ≤50%, unstable angina) 3、Severe pulmonary comorbidities (e.g., DLCO ≤65%, FEV1 ≤65%) 4、Severe renal comorbidities (e.g., serum creatinine \>2×upper limit of normal (ULN), creatinine clearance \<45 mL/min by any formula) 5、Severe hepatic comorbidities (e.g., total bilirubin \>1.5×ULN, AST/ALT/ALP \>3×ULN) 6、Active infection refractory to antimicrobial therapy 7、Documented cognitive impairment 8、Other comorbidities contraindicating intensive chemotherapy (3) Newly diagnosed B-ALL patients aged ≥15 to \<60 years with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons (Fit-Declined), as per NCCN guidelines (e.g., fear of toxicity, financial/social/psychological factors, preference for quality of life).

(4) Patients aged ≥15 years with relapsed/refractory B-ALL or MRD positivity after prior chemotherapy (5) All patients must meet the following organ function requirements:

1. Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram
2. Creatinine clearance ≥30 mL/min (by any formula)
3. ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)
4. ≤Grade 1 dyspnea and oxygen saturation \>91% without supplemental oxygen (6) Ability to understand and voluntarily sign the informed consent form. (7) Life expectancy ≥3 months.

Exclusion Criteria:

1. Presence of central nervous system (CNS) or other extramedullary disease.
2. Concurrent other active malignancies or malignancies requiring treatment.
3. Prior exposure to CD19- or CD22-targeted therapies (including but not limited to CD19-directed CD3 T-cell engager, inotuzumab ozogamicin, CD19 or/and CD22 CAR-T).
4. Use of immunosuppressive agents within 2 weeks prior to signing informed consent, or planned long-term immunosuppressive therapy after enrollment.
5. Active cardiac disease (NYHA Class ≥3 as assessed by medical history and physical examination).
6. Severe chronic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis \[HBsAb-positive, HCVAb-positive\]).

1、Patients with occult or prior HBV infection (defined as HBcAb-positive, HBsAg-negative) are eligible only if HBV DNA PCR is negative, and require monthly HBV DNA monitoring with prophylactic antiviral therapy.

2、HCV antibody-positive patients are eligible only if HCV RNA PCR is negative. 3、History of confirmed severe or persistent veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS).

(7) Bacterial, fungal, viral, mycoplasma, or other infections that are uncontrolled as judged by the investigator; HIV, syphilis, or SARS-CoV-2 infection.

(8) Past or current CNS disorders, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease.

(9) Primary immunodeficiency or active autoimmune disease. (10) History of severe immediate hypersensitivity to any study drugs. (11) Receipt of live vaccine within 6 weeks prior to screening. (12) Psychiatric disorders or other conditions that may compromise compliance with study requirements, treatment, or monitoring.

(13) Pregnant or breastfeeding women, or fertile patients unwilling to use contraception.

(14) Any other condition deemed unsuitable for study participation by the investigator.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Sheng-Li Xue, M.D. — The First Affiliated Hospital of Soochow University
• Study coordinator: Sheng-Li Xue, M.D.
• Email: slxue@suda.edu.cn
• Phone: 008651267781139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.