HSCTPhase 2NCT07443488
Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL
A Phase 2 study testing Olverembatinib+INO in people with HSCT and Ph+ ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Olverembatinib+INO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2026to 31 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.
- (2) Age greater than or equal to 18 years.
- (3) Able to provide informed consent independently.
- (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL/min; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) > 60%, pulmonary artery systolic pressure ≤ 50 mmHg.
- (5) Negative for HIV, HBV, and HCV.
- (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
- (7) Informed consent must be signed before the start of study procedures. For subjects aged 18 years and above, informed consent should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is detrimental to treatment, the legal guardian or immediate family member may sign the informed consent.
Who cannot join
- (1) Mixed lineage leukemia;
- (2) Involvement of the central nervous system or extramedullary infiltration;
- (3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study;
- (4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3);
- (5) History of clinically significant liver diseases, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe/uncontrolled liver diseases, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis;
- (6) Active cardiac disease, defined as one or more of the following: history of any cardiac or vascular disease; history of uncontrolled or symptomatic angina; myocardial infarction within 6 months prior to study enrollment; history of arrhythmias requiring medication or with severe clinical symptoms; uncontrolled or symptomatic congestive heart failure (> New York Heart Association [NYHA] Class 2); ejection fraction below the lower limit of normal; pulmonary artery systolic pressure > 50 mmHg on echocardiography; or clinical symptoms related to pulmonary hypertension;
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- (7) History of severe cardiovascular events (including myocardial infarction, unstable angina, severe arrhythmias, congestive heart failure, etc.) during previous tyrosine kinase inhibitor (TKI) treatment for chronic myeloid leukemia (CML);
- (8) Abnormal coagulation function;
- (9) Known seropositivity for HIV or active hepatitis C virus;
- (10) Patients with psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements;
- (11) Inability or unwillingness to sign the consent form;
- (12) Pregnant or lactating women;
- (13) Patients assessed by the investigator as ineligible due to other special circumstances.
About this study
Official title: A Study on the Efficacy and Safety of Olverembatinib Combined With Inotuzumab Ozogamicin as First-Line Consolidation Therapy Bridging to Hematopoietic Stem Cell Transplantation in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.
Read the detailed description
In the previous study, which employed a regimen of olverembatinib combined with inotuzumab ozogamicin to clear MRD in patients with Ph⁺ ALL before bridging to transplantation, the results indicated that this combination achieved a high MRD clearance rate in patients with poor prognosis, along with a high bridging transplantation rate, significantly improving patient outcomes. In the present study, the investigators propose the use of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation therapy. This approach aims to reduce the number of pre-transplant chemotherapy cycles for patients who do not achieve MRD negativity after initial induction chemotherapy, enabling them to attain deeper remission more rapidly. It is expected to provide more transplantation opportunities, including the potential for autologous hematopoietic stem cell transplantation, for this patient population.
- Being tested
- Olverembatinib+INO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olverembatinib+INODrug
First-Line Consolidation Chemotherapy with Olverembatinib + Inotuzumab Ozogamicin Olverembatinib: 40 mg every other day (QOD), from day 1 to day 28.
Inotuzumab Ozogamicin: 1.2 mg/m² per cycle, administered as:
0.6 mg/m² on day 2 0.6 mg/m² on day 8
| Study group | Role | What they receive |
|---|---|---|
| enhanced consolidation involving Olverembatinib and INO | Experimental | Not described Receives: Drug: Olverembatinib+INO |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD clearance
Measured: one month
Secondary outcomes (5)
Overall Survival
Measured: one year after HSCT
Relapse free survival
Measured: one year after HSCT
Relapse rate
Measured: one year after HSCT
Treatment related mortality
Measured: one year after HSCT
rate of bridging to HSCT
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start14 Mar 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCTStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443488
- Sponsor's protocol ID
- IIT2025119
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 2 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Olverembatinib Combined With Inotuzumab Ozogamicin as First-Line Consolidation Therapy Bridging to Hematopoietic Stem Cell Transplantation in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07443488
- Acronym / sponsor ID
- IIT2025119
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 14 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Mar 2026 (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.
To study the minimal residual disease (MRD) clearance rate of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation chemotherapy in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who have not achieved MRD remission after initial induction chemotherapy.
Detailed description
In the previous study, which employed a regimen of olverembatinib combined with inotuzumab ozogamicin to clear MRD in patients with Ph⁺ ALL before bridging to transplantation, the results indicated that this combination achieved a high MRD clearance rate in patients with poor prognosis, along with a high bridging transplantation rate, significantly improving patient outcomes. In the present study, the investigators propose the use of olverembatinib combined with inotuzumab ozogamicin as first-line consolidation therapy. This approach aims to reduce the number of pre-transplant chemotherapy cycles for patients who do not achieve MRD negativity after initial induction chemotherapy, enabling them to attain deeper remission more rapidly. It is expected to provide more transplantation opportunities, including the potential for autologous hematopoietic stem cell transplantation, for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enhanced consolidation involving Olverembatinib and INO | Experimental | Drug: Olverembatinib+INO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- (1) Clearly diagnosed acute lymphoblastic leukemia, with Philadelphia chromosome positivity or BCR-ABL fusion gene positivity; with CD22 expression on the surface of leukemia cells; failure to achieve minimal residual disease (MRD) negativity after first induction chemotherapy (BCR-ABL fusion gene level ≥ 10-⁴), where the induction regimen is standard chemotherapy combined with any tyrosine kinase inhibitor targeting BCR-ABL1.
- (2) Age greater than or equal to 18 years.
- (3) Able to provide informed consent independently.
- (4) Must have adequate organ function: renal and hepatic functions as follows: AST, ALT, and ALP less than 2 times the upper limit of normal (ULN), total bilirubin less than 1.5 times ULN; creatinine clearance greater than 50 mL/min; pancreatic function: serum amylase not exceeding 1.5 times ULN, serum lipase not exceeding 1.5 times ULN; normal cardiac function: ejection fraction (EF) > 60%, pulmonary artery systolic pressure ≤ 50 mmHg.
- (5) Negative for HIV, HBV, and HCV.
Key exclusion criteria (13 listed)
- (1) Mixed lineage leukemia;
- (2) Involvement of the central nervous system or extramedullary infiltration;
- (3) Patients with concurrent other malignancies; or those assessed by the investigator as having concomitant diseases that severely endanger the patient's life or affect the completion of the study;
- (4) Patients with severe allergy to the components or excipients of InO (≥ Grade 3);
- (5) History of clinically significant liver diseases, such as hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); or severe/uncontrolled liver diseases, such as cirrhosis, decompensated liver disease, acute or chronic hepatitis;
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 |
|---|---|---|
| Olverembatinib+INOFirst-Line Consolidation Chemotherapy with Olverembatinib + Inotuzumab Ozogamicin Olverembatinib: 40 mg every other day (QOD), from day 1 to day 28. Inotuzumab Ozogamicin: 1.2 mg/m² per cycle, administered as: 0.6 mg/m² on day 2 0.6 mg/m² on day 8 | Drug | enhanced consolidation involving Olverembatinib and INO |
Primary outcome
MRD clearance
Time frame: one month
5 secondary outcomes
Overall Survival
Time frame: one year after HSCT
Relapse free survival
Time frame: one year after HSCT
Relapse rate
Time frame: one year after HSCT
Treatment related mortality
Time frame: one year after HSCT
rate of bridging to HSCT
Time frame: one year
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 2 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olverembatinib+INO in people with HSCT and Ph+ ALL, run by Institute of Hematology & Blood Diseases Hospital, 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 7 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 clearance (time frame: one month). 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 2 Mar 2026.