Acute Lymphocytic LeukemiaPhase 2NCT05456698
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
A Phase 2 study testing Inotuzumab ozogamicin in people with Acute Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- Inotuzumab ozogamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2022to 5 Nov 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
- Age ≥18 years
- ECOG PS score: 0 to 2
- Functions of the main organs are normal, if the following criteria are met:
- Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
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- Serum creatinine ≤ 1.5 × ULN
- Creatinine clearance ≥ 30 ml/min
- No active or co-existing malignancy with a life expectancy of less than 12 months
- Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.
Who cannot join
- Mixed lineage leukemia
- Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
- Patients with severe and / or uncontrolled diseases, such as:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
- Known to be human immunodeficiency virus positive (HIV+)
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- Active and uncontrolled disease/infection as judged by the treating physician
- Active central nervous system (CNS) or extramedullary disease
- Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
- Pregnant or nursing women
- Unable or unwilling to sign the consent form
- Monoclonal antibodies therapy within 2 weeks before study entry
- Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
- Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
- Patients in other situations who are evaluated by the investigator to be ineligible
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
- Conditions
- Acute Lymphocytic Leukemia
- 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
Also called CMC-544
Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15.
Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Inotuzumab Ozogamicin | Experimental | Each subject will be treated with Inotuzumab Ozogamicin Receives: Drug: Inotuzumab ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD negativity rate within the first treatment cycle
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (5)
Complete MRD response rates
Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
Measured: At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Duration of MRD negativity rate
The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
Measured: From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
Measured: From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Relapse-free Survival (RFS)
RFS is defined as the time from the date of CR until the date of relapse or death
Measured: Up to 5 years from enrollment
Overall Survival (OS)
OS is defined as the time from enrollment to date of death due to any cause.
Measured: Up to 5 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start18 Oct 2022
- Primary completion5 Nov 2025
- Study completion5 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456698
- Sponsor's protocol ID
- IIT2022011
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
- ClinicalTrials.gov ID
- NCT05456698
- Acronym / sponsor ID
- IIT2022011
- Conditions
- Acute Lymphocytic Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2030 (estimated)
- First posted
- 13 Jul 2022 (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.
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inotuzumab Ozogamicin | Experimental | Drug: Inotuzumab ozogamicinEach subject will be treated with Inotuzumab Ozogamicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
- Age ≥18 years
- ECOG PS score: 0 to 2
- Functions of the main organs are normal, if the following criteria are met:
- No active or co-existing malignancy with a life expectancy of less than 12 months
Key exclusion criteria (15 listed)
- Mixed lineage leukemia
- Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
- Patients with severe and / or uncontrolled diseases, such as:
- Pregnant or nursing women
- Unable or unwilling to sign the consent form
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 ozogamicinAlso: CMC-544Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15. Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity. | Drug | Inotuzumab Ozogamicin |
Primary outcome
MRD negativity rate within the first treatment cycle
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
5 secondary outcomes
Complete MRD response rates
Time frame: At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Duration of MRD negativity rate
Time frame: From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
Time frame: From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
Relapse-free Survival (RFS)
Time frame: Up to 5 years from enrollment
Overall Survival (OS)
Time frame: Up to 5 years from enrollment
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A Phase 2 study testing Inotuzumab ozogamicin in people with Acute Lymphocytic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 10 inclusion and 15 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 16 Apr 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?
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?
MRD negativity rate within the first treatment cycle (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 16 Apr 2026.