Acute Lymphoblastic LeukaemiaNCT07238907
A Multi-center Retrospective Study of INO Treating B-ALL
An observational study of Acute Lymphoblastic Leukaemia and Acute Lymphoblastic Leukaemias (ALL), run by Ruijin Hospital at 1 site in China.
Trial summary
This multi-center retrospective study aims to evaluate the efficacy and safety of inotuzumab ozogamicin in adults B-ALL of different subgroups. This study is a retrospective study. Data will be collected from Electronic Medical Record, interventions will not be implemented on patients. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Acute Lymphoblastic Leukaemia, Acute Lymphoblastic Leukaemias (ALL), Inotuzumab Ozogamicin
- What is being tested?
- Inotuzumab Ozogamicin
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Jul 2026
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients received INO-based therapy in all participant center of this study
Who may be able to join
- Age between ≥16 and ≤80 years at screening, no gender restrictions
- Be diagnosed with B-ALL
- Appropirate organ function, meeting the following criteria:
- Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) ≤3 times ULN;
- Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
- Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
- Left ventricular ejection fraction (LVEF) ≥50%;
Who cannot join
- Active infection at screening.
- Any of the following cardiac conditions:
- NYHA Class III or IV congestive heart failure;
- Severe arrhythmia requiring treatment;
- Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
- Unstable angina;
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- Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
- Clinically significant valvular disease;
- Other cardiac conditions deemed unsuitable by the investigator;
- History of epilepsy, cerebellar disease, or other active central nervous system disorders;
- History of hypersensitivity to any component of the investigational product.
- Life expectancy of less than three months;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
This multi-center retrospective study aims to evaluate the efficacy and safety of inotuzumab ozogamicin in adults B-ALL of different subgroups. This study is a retrospective study. Data will be collected from Electronic Medical Record, interventions will not be implemented on patients.
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Lymphoblastic Leukaemias (ALL), Inotuzumab Ozogamicin, Venetoclax
- Being tested
- 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.
Inotuzumab OzogamicinDrug
All patients have received Inotuzumab Ozogamicin
| Study group | Role | What they receive |
|---|---|---|
| observation group | Not described Receives: Drug: Inotuzumab Ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Measured: Till the end of the study, up to 12 months
Secondary outcomes (4)
minimal residual disease negativity rate
The proportion of patients who reach MRD negative in all patients reached CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
Measured: Till the end of the study, up to 12 months
overall survival
Interval from the date of the feedback to the time of death due to any reason. Evaluation of OS will be based on follow-up results.
Measured: Till the end of the study, up to 12 months
Relapse-free survival
Interval from the date of reception of the INO-based therapy to the time of hematological recurrence or death from any cause. Evaluation of RFS will be based on follow-up results.
Measured: Till the end of the study, up to 12 months
Hematological toxicity: neutropenia, thrombocytopenia, febrile neutropenia, anemia, bone marrow suppression Non hematological toxicity: SOS,TLS, peripheral edema, fever, fatigue, MODS, infection, liver dysfunction, renal dysfunction et al.
Hematological toxicity includes: neutropenia, thrombocytopenia, febrile neutropenia, anemia, and bone marrow suppression Non hematological toxicity includes sinus obstruction syndrome(SOS), tumor lysis syndrome(TLS), peripheral edema, fever, fatigue, multiple organ dysfunction syndrome(MODS), infection, liver dysfunction, renal dysfunction, abnormal blood electrolytes, and infusion reactions.
All AEs will be assessed by CTCAE v5.0
Measured: Till the end of the study, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jun 2022
- Primary completion30 Jun 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukaemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238907
- Sponsor's protocol ID
- RJ-ALL 2025-B03
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Retrospective Study of Inotuzumab Ozogamicin Treating Acute B-cell Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07238907
- Acronym / sponsor ID
- RJ-ALL 2025-B03
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Lymphoblastic Leukaemias (ALL), Inotuzumab Ozogamicin, Venetoclax
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Nov 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 multi-center retrospective study aims to evaluate the efficacy and safety of inotuzumab ozogamicin in adults B-ALL of different subgroups. This study is a retrospective study. Data will be collected from Electronic Medical Record, interventions will not be implemented on patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Drug: Inotuzumab Ozogamicin |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients received INO-based therapy in all participant center of this study
Key inclusion criteria (8 listed)
- Age between ≥16 and ≤80 years at screening, no gender restrictions
- Be diagnosed with B-ALL
- Appropirate organ function, meeting the following criteria:
Key exclusion criteria (13 listed)
- Active infection at screening.
- Any of the following cardiac conditions:
- History of epilepsy, cerebellar disease, or other active central nervous system disorders;
- History of hypersensitivity to any component of the investigational product.
- Life expectancy of less than three months;
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 |
|---|---|---|
| Inotuzumab OzogamicinAll patients have received Inotuzumab Ozogamicin | Drug | observation group |
Primary outcome
overall response rate
Time frame: Till the end of the study, up to 12 months
The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
4 secondary outcomes
minimal residual disease negativity rate
Time frame: Till the end of the study, up to 12 months
overall survival
Time frame: Till the end of the study, up to 12 months
Relapse-free survival
Time frame: Till the end of the study, up to 12 months
Hematological toxicity: neutropenia, thrombocytopenia, febrile neutropenia, anemia, bone marrow suppression Non hematological toxicity: SOS,TLS, peripheral edema, fever, fatigue, MODS, infection, liver dysfunction, renal dysfunction et al.
Time frame: Till the end of the study, up to 12 months
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 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukaemia and Acute Lymphoblastic Leukaemias (ALL), run by Ruijin Hospital 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: Till the end of the study, up to 12 months). 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 25 Nov 2025.