Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
Recruiting now · Phase 2
Conditions studied: Acute Lymphoblastic Leukemia, Immunotherapy, Blinatumomab, Inotuzumab Ozogamicin
In brief
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.
Key facts
- Study ID
- NCT06985485
- Run by
- The First Affiliated Hospital of Soochow University
- People needed
- 26
- Starts
- 2025-05-17
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-24
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL) patients aged ≥60 years, as per NCCN guidelines.
- 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:
- Left ventricular ejection fraction (LVEF) ≥40% by echocardiogram
- Creatinine clearance ≥30 mL/min (by any formula)
- ALT and AST ≤3×ULN, total bilirubin ≤2×ULN (unless attributed to leukemia)
- ≤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.
You may not qualify if…
- Presence of central nervous system (CNS) or other extramedullary disease.
- Concurrent other active malignancies or malignancies requiring treatment.
- 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).
- Use of immunosuppressive agents within 2 weeks prior to signing informed consent, or planned long-term immunosuppressive therapy after enrollment.
- Active cardiac disease (NYHA Class ≥3 as assessed by medical history and physical examination).
- 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 is running
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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