Acute Lymphoblastic LeukemiaPhase 2NCT06985485
Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy
A Phase 2 study testing Blinatumomab and Inotuzumab Ozogamicin in people with Acute Lymphoblastic Leukemia and Immunotherapy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Immunotherapy, Blinatumomab
- What is being tested?
- Blinatumomab and Inotuzumab Ozogamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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]).
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- 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).
- Bacterial, fungal, viral, mycoplasma, or other infections that are uncontrolled as judged by the investigator; HIV, syphilis, or SARS-CoV-2 infection.
- Past or current CNS disorders, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease.
- 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.
- Pregnant or breastfeeding women, or fertile patients unwilling to use contraception.
- Any other condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Sheng-Li Xue, M.D., +8651267781139, slxue@suda.edu.cn
About this study
Official title: A Phase II Trial of Sequential Blinatumomab and Inotuzumab Ozogamicin in Newly Diagnosed (Unfit/Fit-Declined), Relapsed/Refractory, and MRD-Positive B-ALL
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.
- Being tested
- Blinatumomab and Inotuzumab Ozogamicin
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinatumomab and Inotuzumab OzogamicinDrug
Also called Full-Course Immunotherapy
Subjects who meet the study criteria during screening will receive induction therapy consisting of low-intensity chemotherapy combined with a CD19-directed CD3 T-cell engager with or without TKIs. Regimen includes dexamethasone, vindesine, followed by blinatumomab dosed by body weight: pts ≥45 kg receive fixed dosing (9 µg/day days 1-7, 28 µg/day days 8-28), pts <45 kg receive BSA-adjusted dosing (5 µg/m²/day days 1-7, 15 µg/m²/day days 8-28). Philadelphia chromosome-positive ALL pts receive second-generation TKIs, with subsequent switch to third-generation TKIs or asciminib upon resistance. If morphologic remission is not achieved after initial therapy, a salvage cycle with InO will be administered. Post-remission consolidation chemotherapy includes high-dose methotrexate followed by sequential immunotherapy: BiTE (per weight-stratified dosing), then after a 2-week break, InO (0.8 mg/m² on day 1), followed by another 2-week break.This sequence is repeated for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Unfit and Fit-Decline B-ALL | Experimental | Newly diagnosed patients who are either: Unfit for intensive chemotherapy, defined as those whose physical conditions (e.g., age, comorbidities, organ dysfunction) preclude tolerance of standard intensive regimens as judged by investigators; or Fit-Declined, defined as patients with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons(e.g., fear of toxicity, personal preference). Patients with measurable residual disease (MRD) positivity and relapsed or refractory B-ALL following prior chemotherapy (without prior exposure to CD19/CD22-targeted therapies or CAR-T). A low-intensity chemotherapy regimen combined with a sequential treatment regimen of CD19-directed CD3 T-cell engager and inotuzumab ozogamicin is implemented. Receives: Drug: Blinatumomab and Inotuzumab Ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Measured: 2 years
Secondary outcomes (6)
CR rate(CRR)
CR rate (CR defined as bone marrow blasts < 5% and no Auer rods, absence of extramedullary disease, ANC ≥ 1.0 × 109/L [1000/µL], platelet count ≥ 100 × 109/L [100,000/µL], and independence of RBC transfusions).
Measured: 2 years
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the rate of CR, CRi (including complete remission with incomplete platelet recovery [CRp], PR, and MLFS.
Measured: 2 years
Event-free survival(EFS)
Event-free survival (EFS) is defined as the time from the start of treatment until treatment failure, relapse from remission, or death from any cause, whichever occurs first.
Measured: 2 years
Relapse-free survival(RFS)
Relapse-free survival(RFS) is the time from achievement of complete remission (CR) to the first documented relapse or death from any cause. Patients who die without evidence of relapse are typically censored at the last disease-free assessment.
Measured: 2 years
Cumulative incidence of relapse(CIR)
It is measured the date from complete remission to hematological relapse or molecular relapse was recorded. Patients who had no relapse at the last follow-up were considered as censored data, and non-relapse death was regarded as a competing risk event.
Measured: 2 years
Non-relapse mortality(NRM)
It is measured the probability of death attributable to treatment-related complications or comorbidities, excluding disease relapse/progression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start17 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
- Investigators
- Sheng-Li Xue, M.D., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985485
- Sponsor's protocol ID
- SZBALL03
- Status last verified
- Mar 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sequential Blinatumomab and Inotuzumab Ozogamicin in Newly Diagnosed (Unfit/Fit-Declined), Relapsed/Refractory, and MRD-Positive B-ALL
- ClinicalTrials.gov ID
- NCT06985485
- Acronym / sponsor ID
- SZBALL03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 17 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unfit and Fit-Decline B-ALL | Experimental | Drug: Blinatumomab and Inotuzumab OzogamicinNewly diagnosed patients who are either: Unfit for intensive chemotherapy, defined as those whose physical conditions (e.g., age, comorbidities, organ dysfunction) preclude tolerance of standard intensive regimens as judged by investigators; or Fit-Declined, defined as patients with good performance status and adequate organ function who decline intensive chemotherapy for subjective reasons(e.g., fear of toxicity, personal preference). Patients with measurable residual disease (MRD) positivity and relapsed or refractory B-ALL following prior chemotherapy (without prior exposure to CD19/CD22-targeted therapies or CAR-T). A low-intensity chemotherapy regimen combined with a sequential treatment regimen of CD19-directed CD3 T-cell engager and inotuzumab ozogamicin is implemented. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinatumomab and Inotuzumab OzogamicinAlso: Full-Course ImmunotherapySubjects who meet the study criteria during screening will receive induction therapy consisting of low-intensity chemotherapy combined with a CD19-directed CD3 T-cell engager with or without TKIs. Regimen includes dexamethasone, vindesine, followed by blinatumomab dosed by body weight: pts ≥45 kg receive fixed dosing (9 µg/day days 1-7, 28 µg/day days 8-28), pts <45 kg receive BSA-adjusted dosing (5 µg/m²/day days 1-7, 15 µg/m²/day days 8-28). Philadelphia chromosome-positive ALL pts receive second-generation TKIs, with subsequent switch to third-generation TKIs or asciminib upon resistance. If morphologic remission is not achieved after initial therapy, a salvage cycle with InO will be administered. Post-remission consolidation chemotherapy includes high-dose methotrexate followed by sequential immunotherapy: BiTE (per weight-stratified dosing), then after a 2-week break, InO (0.8 mg/m² on day 1), followed by another 2-week break.This sequence is repeated for 4 cycles. | Drug | Unfit and Fit-Decline B-ALL |
Primary outcome
Overall Survival(OS)
Time frame: 2 years
It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
6 secondary outcomes
CR rate(CRR)
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Event-free survival(EFS)
Time frame: 2 years
Relapse-free survival(RFS)
Time frame: 2 years
Cumulative incidence of relapse(CIR)
Time frame: 2 years
Non-relapse mortality(NRM)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng-Li Xue, M.D. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blinatumomab and Inotuzumab Ozogamicin in people with Acute Lymphoblastic Leukemia and Immunotherapy, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Li Xue, M.D. (008651267781139, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.