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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of immunotherapy for patients with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) who choose not to undergo traditional chemotherapy. The study will look at the effects of two specific treatments, blinatumomab and inotuzumab ozogamicin, given in sequence. The main goal is to see how long patients can live after starting treatment, but the researchers will also track other important outcomes like how many patients go into complete remission and how long they can stay free from the disease.

To be eligible for this trial, participants must be at least 15 years old and newly diagnosed with B-ALL. They should either be older than 60 or between 15 and 60 and unable to tolerate intensive chemotherapy due to health issues. Some of these health issues could include severe heart or lung problems or other serious conditions. Alternatively, younger patients who are physically fit but choose not to have chemotherapy for personal reasons may also join. Participants will be closely monitored throughout the study to assess the safety and effectiveness of the treatments. It's important to note that this trial is not yet recruiting participants, and those interested will need to provide informed consent before taking part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -
• • (1) Newly diagnosed Ph- B-ALL or Ph+ B-ALL patients aged ≥60 years, as per the NCCN 2024 guidelines.
• (2) Newly diagnosed Ph- B-ALL or Ph+ B-ALL patients aged ≥15 and \<60 years who are unfit for intensive chemotherapy, as per the NCCN 2024 guidelines, and have at least one of the following:
• • 1. ECOG score ≥2.
• • 2. Severe cardiac comorbidities (e.g., treated congestive heart failure, echocardiogram LVEF ≤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 \>3.0× ULN).
• • 6. Active infection unresponsive to antimicrobial therapy.
• • 7. Cognitive impairment.
• • 8. Other comorbidities contraindicating chemotherapy. (3) Newly diagnosed Ph- B-ALL or Ph+ B-ALL patients aged ≥18 years who are physically fit and have normal organ function but refuse intensive chemotherapy for subjective reasons (e.g., fear of toxicity, financial/social/psychological factors, preference for improving quality of life), as per the NCCN 2024 guidelines.
• (4) Adequate major organ function:
• • 1. Echocardiogram LVEF ≥50%.
• • 2. Serum creatinine ≤2× ULN or creatinine clearance ≥45 mL/min by any formula.
• • 3. ALT/AST ≤3× ULN, total bilirubin ≤2× ULN (excluding leukemia-related cases).
• • 4. ≤Grade 1 dyspnea , oxygen saturation \>91% without supplemental oxygen. (5) Ability to understand and voluntarily sign the informed consent form. (6) Life expectancy ≥3 months.
• Exclusion Criteria:
• • 1. Presence of extramedullary disease.
• • 2. Concurrent other active or treatment-requiring malignancies.
• • 3. Prior CD19/CD22-targeted therapy.
• • 4. Immunosuppressants or steroids used within 2 weeks before consent, or planned long-term use post-consent.
• • 5. Active NYHA Class ≥3 heart disease.
• • 6. Active hepatitis; history of HBV (HBsAg+) or HCV (HCV antibody+). Occult/precore HBV (HBcAb+, HBsAg-) allowed if HBV DNA PCR-negative, with monthly monitoring. HCV antibody+ patients can enroll if HCV RNA PCR-negative.
• • 7. Uncontrolled infections, including HIV, syphilis, or COVID-19.
• • 8. Past/current CNS disorders (e.g., seizures, cerebrovascular events, dementia, cerebellar disease, CNS autoimmune diseases).
• • 9. Primary immunodeficiency or active autoimmune disease.
• • 10. History of severe immediate hypersensitivity to any study drugs.
• • 11. Live vaccine receipt within 6 weeks before screening.
• • 12. Psychiatric conditions or inability to comply with study requirements.
• • 13. Pregnant/breastfeeding women, or fertile patients not using contraception.
• • 14. Investigator-assessed unsuitability for the study.