Status:
RECRUITING
Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Lymphoblastic Leukemia
Immunotherapy
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
This trial is a non-blinded, single-center, open-label, single-arm clinical study to investigate a full-course immunotherapy regimen in Unfit or Fit B-cell acute lymphoblastic leukemia (B-ALL) patient...
Eligibility Criteria
Inclusion
- \-
- (1) Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per the NCCN 2024 guidelines.
- (2) Newly diagnosed B-ALL patients aged ≥15 and \<60 years who are unfit for intensive chemotherapy(Unfit), as per the NCCN 2024 guidelines, and have at least one of the following:
- ECOG score ≥2.
- Severe cardiac comorbidities (e.g., treated congestive heart failure, echocardiogram LVEF ≤50%, unstable angina).
- Severe pulmonary comorbidities (e.g., DLCO ≤65%, FEV1 ≤65%).
- Severe renal comorbidities (e.g., serum creatinine \>2×upper limit of normal (ULN), creatinine clearance \<45 mL/min by any formula).
- Severe hepatic comorbidities (e.g., total bilirubin \>1.5× ULN, AST/ALT/ALP \>3.0× ULN).
- Active infection unresponsive to antimicrobial therapy.
- Cognitive impairment.
- Other comorbidities contraindicating chemotherapy. (3) Newly diagnosed B-ALL patients aged ≥15 years who are physically fit and have normal organ function but refuse intensive chemotherapy for subjective reasons(Fit-Declined) (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:
- Echocardiogram LVEF ≥40%.
- creatinine clearance ≥30 mL/min by any formula.
- ALT/AST ≤3× ULN, total bilirubin ≤2× ULN (excluding leukemia-related cases).
- ≤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
- Presence of extramedullary disease.
- Concurrent other active or treatment-requiring malignancies.
- Prior CD19/CD22-targeted therapy.
- Use of immunosuppressive agents within 2 weeks before signing informed consent, or planned long-term immunosuppressive therapy after enrollment.
- Active NYHA Class ≥3 heart disease.
- Severe chronic liver disease (e.g., cirrhosis, nodular regenerative hyperplasia, active hepatitis \[HBsAb-positive, HCVAb-positive\]).
- Occult or resolved HBV infection (defined as HBcAb-positive but HBsAg-negative) is allowed only if HBV DNA PCR is negative, with mandatory monthly HBV DNA monitoring and prophylactic antiviral therapy.
- HCV antibody-positive patients are eligible only if HCV RNA PCR is negative.
- History of severe or persistent VOD/SOS (veno-occlusive disease/sinusoidal obstruction syndrome).
- Uncontrolled bacterial, fungal, viral, mycoplasma, or other infections as judged by the investigator, including HIV, syphilis, or SARS-CoV-2 infection.
- Past/current CNS disorders (e.g., seizures, cerebrovascular events, dementia, cerebellar disease, CNS autoimmune diseases).
- Primary immunodeficiency or active autoimmune disease.
- History of severe immediate hypersensitivity to any study drugs.
- Live vaccine receipt within 6 weeks before screening.
- Psychiatric disorders or other conditions that may compromise compliance with study procedures, treatment, or monitoring.
- Pregnant/breastfeeding women, or fertile patients not using contraception.
- Any other condition deemed unsuitable for study participation by the investigator.
Key Trial Info
Start Date :
May 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06985485
Start Date
May 17 2025
End Date
December 31 2027
Last Update
August 28 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006