Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Phase 2Ph+ ALL-2026NCT07840976
Immunotargeted Therapy Plus Low-Dose Chemotherapy in Newly Diagnosed Adult Ph+ B-ALL
A Phase 2 study testing olverembatinib, Venetoclax and Inotuzumab Ozogamicin (IO) in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)
- What is being tested?
- olverembatinib, Venetoclax and Inotuzumab Ozogamicin (IO)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2026to 31 May 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
- Age ≥ 18 years
- Newly diagnosed, previously untreated Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) confirmed by cytogenetics and/or molecular testing
- Leukemic blasts expressing CD22
- Adequate organ function (renal, hepatic, cardiac)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 3 months
- Written informed consent obtained prior to any study-related procedures
Who cannot join
- Prior systemic anti-leukemic therapy, including chemotherapy, targeted therapy, or immunotherapy
- History of chronic myeloid leukemia (CML) or other hematologic malignancies
- Central nervous system (CNS) leukemia or extramedullary disease at diagnosis
- Uncontrolled active infection or severe comorbidities
- HIV positivity or known hepatitis B/C infection with active viral replication
- Pregnant or breastfeeding
- Inability to comply with study procedures or follow-up requirements
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
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)
Tianjin, Tianjin Municipality, 301600
Runxia Gu, +86-22-23608095, gurunxia@ihcams.ac.cn
About this study
Official title: A Prospective, Umbrella, Phase 2 Study of Immunotargeted Agents Combined With Low-Dose Chemotherapy in Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive B-Cell Acute Lymphoblastic Leukemia
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL).
As an umbrella trial, all patients share the same target disease (newly diagnosed Ph+ B-ALL) and receive a uniform induction backbone consisting of multi-targeted immunotherapy, targeted therapy, and reduced-intensity chemotherapy. After induction, patients are stratified and assigned to two distinct consolidation pathways based on clinical condition, performance status, resource availability, and patient preference:
Read more
Pathway A: Consolidation with CD19-directed CAR-T cell therapy to achieve deep molecular remission; Pathway B: Consolidation with sequential immunochemotherapy to maximize minimal residual disease (MRD) clearance.
A backup chemotherapy backbone is provided for patients ineligible for antibody therapy. All patients, regardless of consolidation pathway, proceed to a unified long-term maintenance regimen. The primary endpoint is the complete molecular remission (CMR) rate after one cycle of induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated per NCI CTCAE version 5.0.
- Being tested
- olverembatinib, Venetoclax, Inotuzumab Ozogamicin (IO), Blinatumomab, CD19-directed chimeric antigen receptor (CAR-T) T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olverembatinibDrug
Third-generation tyrosine kinase inhibitor (TKI) targeting BCR::ABL1, administered orally daily as part of induction, consolidation, and maintenance therapy.
VenetoclaxDrug
BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
Inotuzumab Ozogamicin (IO)Drug
Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
BlinatumomabDrug
CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy.
CD19-directed chimeric antigen receptor (CAR-T) T cellsBiological
Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients.
| Study group | Role | What they receive |
|---|---|---|
| Immunotargeted Therapy + Low-Dose Chemotherapy Arm | Experimental | All patients receive a uniform induction therapy backbone combining targeted therapy, immunotherapy, and reduced-intensity chemotherapy. After induction, patients are stratified into two consolidation pathways based on clinical status: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to a unified long-term maintenance regimen. Receives: Drug: olverembatinib; Drug: Venetoclax; Drug: Inotuzumab Ozogamicin (IO); Drug: Blinatumomab; Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy
The proportion of patients achieving complete molecular remission (CMR), defined as undetectable BCR::ABL1 transcript by quantitative PCR (BCR::ABL1/ABL1 ratio < 0.001%), after 1 cycle of induction therapy.
Measured: At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)
Secondary outcomes (6)
3-Month Complete Remission (CR)
Measured: 3 months after study enrollment
3-Month MRD Negativity Rates
Measured: 3 months after study enrollment
2-Year Overall Survival (OS)
OS is defined as the time from study enrollment to death from any cause.
Measured: 2 years after the last patient enrollment
2-Year Disease-Free Survival (DFS)
DFS is defined as the time from study enrollment to disease relapse or death from any cause.
Measured: 2 years after the last patient enrollment
2-Year Event-Free Survival (EFS)
EFS is defined as the time from study enrollment to first occurrence of predefined adverse events, disease progression or death.
Measured: 2 years after the last patient enrollment
Incidence of Treatment-Related Adverse Events (TRAEs)
Number and severity of adverse events graded according to NCI CTCAE version 5.0.
Measured: From study enrollment to 60 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Studies 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
- Sequential
- Model description
- This is an umbrella trial with a sequential treatment design. All patients receive a uniform induction therapy backbone, then are stratified into two consolidation pathways based on clinical status and patient preference: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to the same maintenance phase.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840976
- Sponsor's protocol ID
- IIT2026061
- Other IDs
- IIT2026061-EC-1
- Acronym
- Ph+ ALL-2026
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 25 Sep 2026
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Umbrella, Phase 2 Study of Immunotargeted Agents Combined With Low-Dose Chemotherapy in Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07840976
- Acronym / sponsor ID
- Ph+ ALL-2026 / IIT2026061
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 25 Sep 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.
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 22 adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (ALL).
As an umbrella trial, all patients share the same target disease (newly diagnosed Ph+ B-ALL) and receive a uniform induction backbone consisting of multi-targeted immunotherapy, targeted therapy, and reduced-intensity chemotherapy. After induction, patients are stratified and assigned to two distinct consolidation pathways based on clinical condition, performance status, resource availability, and patient preference:
Pathway A: Consolidation with CD19-directed CAR-T cell therapy to achieve deep molecular remission; Pathway B: Consolidation with sequential immunochemotherapy to maximize minimal residual disease (MRD) clearance.
A backup chemotherapy backbone is provided for patients ineligible for antibody therapy. All patients, regardless of consolidation pathway, proceed to a unified long-term maintenance regimen. The primary endpoint is the complete molecular remission (CMR) rate after one cycle of induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated per NCI CTCAE version 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an umbrella trial with a sequential treatment design. All patients receive a uniform induction therapy backbone, then are stratified into two consolidation pathways based on clinical status and patient preference: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to the same maintenance phase.
| Arm | Type | Receives |
|---|---|---|
| Immunotargeted Therapy + Low-Dose Chemotherapy Arm | Experimental | Drug: olverembatinib, Drug: Venetoclax, Drug: Inotuzumab Ozogamicin (IO), Drug: Blinatumomab, Biological: CD19-directed chimeric antigen receptor (CAR-T) T cellsAll patients receive a uniform induction therapy backbone combining targeted therapy, immunotherapy, and reduced-intensity chemotherapy. After induction, patients are stratified into two consolidation pathways based on clinical status: 1) CD19 CAR-T cell therapy; 2) sequential immunochemotherapy. All patients proceed to a unified long-term maintenance regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Newly diagnosed, previously untreated Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) confirmed by cytogenetics and/or molecular testing
- Leukemic blasts expressing CD22
- Adequate organ function (renal, hepatic, cardiac)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (7 listed)
- Prior systemic anti-leukemic therapy, including chemotherapy, targeted therapy, or immunotherapy
- History of chronic myeloid leukemia (CML) or other hematologic malignancies
- Central nervous system (CNS) leukemia or extramedullary disease at diagnosis
- Uncontrolled active infection or severe comorbidities
- HIV positivity or known hepatitis B/C infection with active viral replication
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 |
|---|---|---|
| olverembatinibThird-generation tyrosine kinase inhibitor (TKI) targeting BCR::ABL1, administered orally daily as part of induction, consolidation, and maintenance therapy. | Drug | Immunotargeted Therapy + Low-Dose Chemotherapy Arm |
| VenetoclaxBCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis. | Drug | Immunotargeted Therapy + Low-Dose Chemotherapy Arm |
| Inotuzumab Ozogamicin (IO)Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy. | Drug | Immunotargeted Therapy + Low-Dose Chemotherapy Arm |
| BlinatumomabCD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy. | Drug | Immunotargeted Therapy + Low-Dose Chemotherapy Arm |
| CD19-directed chimeric antigen receptor (CAR-T) T cellsAutologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients. | Biological | Immunotargeted Therapy + Low-Dose Chemotherapy Arm |
Primary outcome
Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy
Time frame: At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)
The proportion of patients achieving complete molecular remission (CMR), defined as undetectable BCR::ABL1 transcript by quantitative PCR (BCR::ABL1/ABL1 ratio < 0.001%), after 1 cycle of induction therapy.
6 secondary outcomes
3-Month Complete Remission (CR)
Time frame: 3 months after study enrollment
3-Month MRD Negativity Rates
Time frame: 3 months after study enrollment
2-Year Overall Survival (OS)
Time frame: 2 years after the last patient enrollment
2-Year Disease-Free Survival (DFS)
Time frame: 2 years after the last patient enrollment
2-Year Event-Free Survival (EFS)
Time frame: 2 years after the last patient enrollment
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: From study enrollment to 60 days after the last treatment
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 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)
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Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALL
ALL
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingPhase 1
Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Not yet recruitingPhase 1
Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
RecruitingPhase 1/2
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Philadelphia Chromosome-Positive, Acute Lymphoblastic Leukemia
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.
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 olverembatinib, Venetoclax and Inotuzumab Ozogamicin (IO) in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), 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 7 inclusion and 7 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 25 Sep 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 Ying Wang, MD, PhD (+86 22-23608095, wangying1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Molecular Remission (CMR) Rate After 1 Cycle of Induction Therapy (time frame: At the end of Cycle 1 (each cycle is 28 days, approximately 4 weeks from enrollment)). 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 Sep 2026.