Ph+ ALLNCT07493161
Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL
A study testing Olverembatinib, Venetoclax and Blinatumomab in people with Ph+ ALL, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Ph+ ALL
- What is being tested?
- Olverembatinib, Venetoclax and Blinatumomab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 30 Mar 2030
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
- Age ≥ 14 years.
- ECOG performance status ≤ 2.
- Adequate organ function: Total bilirubin <1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine <2x ULN; Cardiac enzymes <2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) >45%.
- Male and female patients of childbearing potential must agree to use effective contraception.
- Signed informed consent.
Who cannot join
- Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
- Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
- Uncontrolled active severe infection.
- Active psychiatric illness that may hinder treatment completion or informed consent.
- Any other condition deemed unsuitable for the study 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
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Hui Wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study
This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction/consolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab-based regimens. The primary endpoint for the venetoclax part is the rate of BCR-ABL < 0.01% at day 90. The primary endpoint for the InO consolidation part is modified event-free survival (EFS) from the start of InO treatment. Key secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of molecular and hematologic relapse, NGS MRD negativity rates, and safety profiles including cardiovascular events and SOS/VOD. The study aims to enroll 110 patients in the initial phase and an additional 78 patients for the InO consolidation phase.
- Conditions
- Ph+ ALL
- Being tested
- Olverembatinib, Venetoclax, Blinatumomab, Chemotherapy Backbone Regimens, Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
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, including T315I mutation.nduction \& Consolidation: 40mg every other day.
After achieving CMR: Reduced to 20mg every other day during maintenance.
VenetoclaxDrug
BCL-2 inhibitor. Used only in the experimental arm.Induction: Ramp-up: 100mg D1, 200mg D2, 400mg D3-28.
Consolidation: 400mg D1-7.
BlinatumomabDrug
CD19/CD3 bispecific T-cell engager (BiTE). Optional add-on therapy 1.Start from 4 cycle.
Duration: 1-4 cycles (each cycle = 28 days), intercalated with chemotherapy cycles.
Note: If ≥3 cycles given,cycle 8 and 9 are omitted.
Chemotherapy Backbone RegimensDrug
Induction (VPO/VPVO): Vincristine + Prednisone + Olverembatinib (± Venetoclax).
Consolidation (VOVP/OVP): Vincristine +Olverembatinib + Prednisone (± Venetoclax).
HD-MTX: High-dose methotrexate with leucovorin rescue in cycle 4,6,8.
ID-AraC: Intermediate-dose cytarabine in cycle 5,7,9.
Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)Other
Recommended for patients with MRD ≥0.01% after two treatment blocks.
Inotuzumab ozogamicinDrug
Optional add-on therapy 2. Start from 4 cycle. at a total dose of 2 mg per cycle. TKI should be discontinued 5 days prior to InO administration, and olverembatinib oral therapy should be resumed one week after InO administration. For patients who remain NGS MRD-positive after one cycle of InO, a repeat cycle of InO may be considered.
Note: If 2 cycles given,cycle 9 are omitted.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy (Chemotherapy + Olverembatinib) | Active comparator | Patients receive a backbone of low-intensity chemotherapy combined with olverembatinib(OVB) .
Induction : Vincristine D1,8,15,22; Prednisone D1-28; Olverembatinib D1-28；
Consolidation 1 \& 2: Olverembatinib D1-28; Prednisone D1-14；Vincristine D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.
Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age .
Maintenance therapy: MM and VP regimen for 2 years. OVB maintenance therapy continues for at least 5 years.
Optional Add-on 1: Patients may receive 1-4 cycles of blinatumomab starting from Cycle 4.
Optional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4
Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment. Receives: Drug: Olverembatinib; Drug: Blinatumomab; Drug: Chemotherapy Backbone Regimens; Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT); Drug: Inotuzumab ozogamicin |
| Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) | Experimental | Patients receive the same backbone as the Control Arm plus the BCL2 inhibitor venetoclax for the first three treatment blocks.
Consolidation 1 \& 2 (OP, 4 weeks each): Olverembatinib (40mg every other day) D1-28; Prednisone D1-14；Vincristine (VCR) D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1.
Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age.
Maintenance therapy:MM and VP regimen with venetoclax for 2 years. Olverembatinib therapy for at least 5 years.
Optional Add-on 1: Patients with financial means may receive 1-4 cycles of blinatumomab starting from Cycle 4.
Optional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4.
Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment. Receives: Drug: Olverembatinib; Drug: Venetoclax; Drug: Blinatumomab; Drug: Chemotherapy Backbone Regimens; Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT); Drug: Inotuzumab ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BCR::ABL1 ≤0.01% at 90 days (after three cycles of treatment)
Measured: up to 90 days
Modified Event-Free Survival (mEFS) from start of InO consolidation
Measured: From the start of InO consolidation therapy up to 2 years
Secondary outcomes (10)
Overall Survival
Measured: up to 5 years
Relapse-Free Survival
Measured: up to 5 years
Cumulative incidence of molecular relapse
Measured: up to 5 years
Cumulative incidence of hematologic relapse
Measured: up to 5 years
Proportion of patients with next-generation sequencing minimal residual disease <0.01% after three cycles of treatment (90 days)
Measured: up to 90 days
Proportion of patients with next-generation sequencing minimal residual disease <0.01% at the end of consolidation therapy
Measured: up to 1 year
Incidence of treatment-related cardiovascular events
Measured: up to 5 years from the initiation of treatment
Proportion of patients with BCR::ABL1 ≤0.01% at completion of consolidation therapy
Measured: up to 9 months
Incidence of SOS/VOD
Measured: From the start of InO consolidation therapy up to 6 months post-treatment
Hematopoietic Stem Cell Transplantation (HSCT) rate
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start10 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph+ ALLStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493161
- Sponsor's protocol ID
- IIT2026022
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2026
- Last updated
- 23 Jul 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study
- ClinicalTrials.gov ID
- NCT07493161
- Acronym / sponsor ID
- IIT2026022
- Conditions
- Ph+ ALL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 25 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.
This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction/consolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab-based regimens. The primary endpoint for the venetoclax part is the rate of BCR-ABL < 0.01% at day 90. The primary endpoint for the InO consolidation part is modified event-free survival (EFS) from the start of InO treatment. Key secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of molecular and hematologic relapse, NGS MRD negativity rates, and safety profiles including cardiovascular events and SOS/VOD. The study aims to enroll 110 patients in the initial phase and an additional 78 patients for the InO consolidation phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy (Chemotherapy + Olverembatinib) | Active comparator | Drug: Olverembatinib, Drug: Blinatumomab, Drug: Chemotherapy Backbone Regimens, Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), Drug: Inotuzumab ozogamicinPatients receive a backbone of low-intensity chemotherapy combined with olverembatinib(OVB) . Induction : Vincristine D1,8,15,22; Prednisone D1-28; Olverembatinib D1-28； Consolidation 1 \& 2: Olverembatinib D1-28; Prednisone D1-14；Vincristine D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1. Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age . Maintenance therapy: MM and VP regimen for 2 years. OVB maintenance therapy continues for at least 5 years. Optional Add-on 1: Patients may receive 1-4 cycles of blinatumomab starting from Cycle 4. Optional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4 Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment. |
| Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) | Experimental | Drug: Olverembatinib, Drug: Venetoclax, Drug: Blinatumomab, Drug: Chemotherapy Backbone Regimens, Other: Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT), Drug: Inotuzumab ozogamicinPatients receive the same backbone as the Control Arm plus the BCL2 inhibitor venetoclax for the first three treatment blocks. Consolidation 1 \& 2 (OP, 4 weeks each): Olverembatinib (40mg every other day) D1-28; Prednisone D1-14；Vincristine (VCR) D1,8. OVB dose is reduced to 20mg every other day for patients achieving CMR after Consolidation 1. Subsequent Chemotherapy: Includes High-Dose Methotrexate (cycles 4, 6, and 8 )and Intermediate-Dose Cytarabine( cycles 5, 7, and 9) with dosing adjusted based on age. Maintenance therapy:MM and VP regimen with venetoclax for 2 years. Olverembatinib therapy for at least 5 years. Optional Add-on 1: Patients with financial means may receive 1-4 cycles of blinatumomab starting from Cycle 4. Optional Add-on 2: Patients who do not receive blinatumomab will receive inotuzumab ozogamicin (InO) starting from Cycle 4. Allogeneic HSCT is an option for patients with NGS MRD ≥0.01% after two cycles of treatment. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
- Age ≥ 14 years.
- ECOG performance status ≤ 2.
- Adequate organ function: Total bilirubin <1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine <2x ULN; Cardiac enzymes <2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) >45%.
- Male and female patients of childbearing potential must agree to use effective contraception.
Key exclusion criteria (6 listed)
- Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
- Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
- Uncontrolled active severe infection.
- Active psychiatric illness that may hinder treatment completion or informed consent.
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, including T315I mutation.nduction \& Consolidation: 40mg every other day. After achieving CMR: Reduced to 20mg every other day during maintenance. | Drug | Standard Therapy (Chemotherapy + Olverembatinib), Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
| VenetoclaxBCL-2 inhibitor. Used only in the experimental arm.Induction: Ramp-up: 100mg D1, 200mg D2, 400mg D3-28. Consolidation: 400mg D1-7. | Drug | Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
| BlinatumomabCD19/CD3 bispecific T-cell engager (BiTE). Optional add-on therapy 1.Start from 4 cycle. Duration: 1-4 cycles (each cycle = 28 days), intercalated with chemotherapy cycles. Note: If ≥3 cycles given,cycle 8 and 9 are omitted. | Drug | Standard Therapy (Chemotherapy + Olverembatinib), Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
| Chemotherapy Backbone RegimensInduction (VPO/VPVO): Vincristine + Prednisone + Olverembatinib (± Venetoclax). Consolidation (VOVP/OVP): Vincristine +Olverembatinib + Prednisone (± Venetoclax). HD-MTX: High-dose methotrexate with leucovorin rescue in cycle 4,6,8. ID-AraC: Intermediate-dose cytarabine in cycle 5,7,9. | Drug | Standard Therapy (Chemotherapy + Olverembatinib), Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
| Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)Recommended for patients with MRD ≥0.01% after two treatment blocks. | Other | Standard Therapy (Chemotherapy + Olverembatinib), Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
| Inotuzumab ozogamicinOptional add-on therapy 2. Start from 4 cycle. at a total dose of 2 mg per cycle. TKI should be discontinued 5 days prior to InO administration, and olverembatinib oral therapy should be resumed one week after InO administration. For patients who remain NGS MRD-positive after one cycle of InO, a repeat cycle of InO may be considered. Note: If 2 cycles given,cycle 9 are omitted. | Drug | Standard Therapy (Chemotherapy + Olverembatinib), Venetoclax-Added Therapy (Chemotherapy + Olverembatinib + Venetoclax) |
Primary outcome
Rate of BCR::ABL1 ≤0.01% at 90 days (after three cycles of treatment)
Time frame: up to 90 days
Modified Event-Free Survival (mEFS) from start of InO consolidation
Time frame: From the start of InO consolidation therapy up to 2 years
10 secondary outcomes
Overall Survival
Time frame: up to 5 years
Relapse-Free Survival
Time frame: up to 5 years
Cumulative incidence of molecular relapse
Time frame: up to 5 years
Cumulative incidence of hematologic relapse
Time frame: up to 5 years
Proportion of patients with next-generation sequencing minimal residual disease <0.01% after three cycles of treatment (90 days)
Time frame: up to 90 days
Proportion of patients with next-generation sequencing minimal residual disease <0.01% at the end of consolidation therapy
Time frame: up to 1 year
Incidence of treatment-related cardiovascular events
Time frame: up to 5 years from the initiation of treatment
Proportion of patients with BCR::ABL1 ≤0.01% at completion of consolidation therapy
Time frame: up to 9 months
Incidence of SOS/VOD
Time frame: From the start of InO consolidation therapy up to 6 months post-treatment
Hematopoietic Stem Cell Transplantation (HSCT) rate
Time frame: up to 5 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 23 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olverembatinib, Venetoclax and Blinatumomab in people with 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 6 inclusion and 6 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 23 Jul 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.
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 Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of BCR::ABL1 ≤0.01% at 90 days (after three cycles of treatment) (time frame: up to 90 days). The study lists 2 primary outcomes in all. 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 23 Jul 2026.