Ph-LikeNCT07454226
ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL
A study testing Olverembatinib, Gecacitinib and Venetoclax in people with Ph-Like and Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Ph-Like, Acute Lymphoblastic Leukemia
- What is being tested?
- Olverembatinib, Gecacitinib and Venetoclax
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 1 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥14 years and ≤60 years, regardless of gender
- ECOG performance status score ≤2
- Male and female participants of childbearing potential agree to and adopt effective contraceptive measures
- Criteria for major organ function assessment: total bilirubin <1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; serum creatinine <2 × ULN; myocardial enzymes <2 × ULN; serum amylase ≤1.5 × ULN; left ventricular ejection fraction (LVEF) >45% as shown by cardiac ultrasound
Who cannot join
- Pregnant women
- Severe uncontrolled active infections
- Mental illnesses that may hinder the completion of treatment or informed consent
- Other conditions deemed unsuitable for this 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, 022-23608456, weihui@ihcams.ac.cn
About this study
Official title: An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL
This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol.
The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.
- Conditions
- Ph-Like, Acute Lymphoblastic Leukemia
- Being tested
- Olverembatinib, Gecacitinib, Venetoclax, Chemotherapy Regimen, Blinatumomab
- 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.
OlverembatinibDrug
Third-generation TKI targeting ABL class fusions. 40 mg every other day, continuous throughout all phases except during HD-MTX.
GecacitinibDrug
JAK1/2 inhibitor targeting JAK pathway alterations. 100 mg twice daily during CAMVT consolidation and maintenance.
VenetoclaxDrug
BCL-2 inhibitor. Escalating doses (100→200→400 mg) during induction; 400 mg during maintenance VP cycles.
Chemotherapy RegimenDrug
Multi-agent chemotherapy including vincristine, prednisone, daunorubicin, cyclophosphamide, pegaspargase, cytarabine, 6-MP, MTX, and dexamethasone per protocol phases.
BlinatumomabDrug
Optional CD19-directed BiTE antibody. 28-day continuous infusions alternating with chemotherapy.
CAR-T Cell TherapyProcedure or surgery
Optional cellular immunotherapy preceded by fludarabine/cyclophosphamide lymphodepletion.
Allogeneic HSCTProcedure or surgery
Stem cell transplantation for eligible patients in first complete remission.
| Study group | Role | What they receive |
|---|---|---|
| ABL pathway group | Experimental | Patients with ABL class fusions receive olverembatinib combined with chemotherapy and venetoclax. Induction (VOVP): vincristine days 1,8,15,22; prednisone days 1-28; venetoclax days 1-28; olverembatinib every other day days 1-28. Consolidation (CAMVT): cyclophosphamide day 1; cytarabine days 1,2,8,9; 6-MP days 1-7; olverembatinib every other day days 1-28 for 2 cycles. Subsequent therapy: HD-MTX (days 1,14; olverembatinib withheld); ID-AraC (days 1-3); VPO (vincristine days 1,8; prednisone days 1-14; olverembatinib every other day); repeat HD-MTX; repeat ID-AraC; COAP (cyclophosphamide day 1; vincristine day 1; cytarabine days 1-7; prednisone days 1-7). Maintenance: alternating MM (6-MP/MTX) and VP + venetoclax, with continuous olverembatinib. Receives: Drug: Olverembatinib; Drug: Venetoclax; Drug: Chemotherapy Regimen; Drug: Blinatumomab; Procedure: CAR-T Cell Therapy; Procedure: Allogeneic HSCT |
| JAK pathway group | Experimental | Patients with JAK pathway alterations receive Gecacitinib combined with chemotherapy and venetoclax. Induction (VDCLP+V): vincristine days 1,8,15,22; daunorubicin days 1-3; cyclophosphamide days 1,15; pegaspargase day 5; prednisone days 1-28; venetoclax days 6-14 (may extend to day 21). Consolidation (CAMVT): cyclophosphamide day 1; cytarabine days 1,2,8,9; 6-MP days 1-7; vincristine day 1; ruxolitinib 100 mg twice daily days 1-28 for 2 cycles. Subsequent therapy (ruxolitinib withheld): early intensification (HVL), delayed intensification (VDLD then CAMVL), repeated once. Maintenance: alternating MM and VP + venetoclax, with continuous ruxolitinib. Receives: Drug: Gecacitinib; Drug: Venetoclax; Drug: Chemotherapy Regimen; Drug: Blinatumomab; Procedure: CAR-T Cell Therapy; Procedure: Allogeneic HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of flow cytometry-minimal residual disease (flow-MRD) negative complete remission at 3 months after treatment initiation
Measured: At 3 months after treatment initiation
Secondary outcomes (7)
Complete response (CR) rate
Measured: At completion of induction therapy
Rate of next-generation sequencing-MRD (NGS-MRD) negative complete remission at 3 months post-treatment
Measured: At 3 months after start of treatment
Overall survival
Measured: Up to 5 years
Disease-free survival
Measured: Up to 5 years
Relapse-free survival
Measured: Up to 5 years
Cumulative incidence of relapse
Measured: Up to 5 years
60-day mortality rate
Measured: At 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start30 May 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 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-LikeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454226
- Sponsor's protocol ID
- IIT2026023
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 May 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL
- ClinicalTrials.gov ID
- NCT07454226
- Acronym / sponsor ID
- IIT2026023
- Conditions
- Ph-Like, Acute Lymphoblastic Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 6 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 open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol.
The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABL pathway group | Experimental | Drug: Olverembatinib, Drug: Venetoclax, Drug: Chemotherapy Regimen, Drug: Blinatumomab, Procedure: CAR-T Cell Therapy, Procedure: Allogeneic HSCTPatients with ABL class fusions receive olverembatinib combined with chemotherapy and venetoclax. Induction (VOVP): vincristine days 1,8,15,22; prednisone days 1-28; venetoclax days 1-28; olverembatinib every other day days 1-28. Consolidation (CAMVT): cyclophosphamide day 1; cytarabine days 1,2,8,9; 6-MP days 1-7; olverembatinib every other day days 1-28 for 2 cycles. Subsequent therapy: HD-MTX (days 1,14; olverembatinib withheld); ID-AraC (days 1-3); VPO (vincristine days 1,8; prednisone days 1-14; olverembatinib every other day); repeat HD-MTX; repeat ID-AraC; COAP (cyclophosphamide day 1; vincristine day 1; cytarabine days 1-7; prednisone days 1-7). Maintenance: alternating MM (6-MP/MTX) and VP + venetoclax, with continuous olverembatinib. |
| JAK pathway group | Experimental | Drug: Gecacitinib, Drug: Venetoclax, Drug: Chemotherapy Regimen, Drug: Blinatumomab, Procedure: CAR-T Cell Therapy, Procedure: Allogeneic HSCTPatients with JAK pathway alterations receive Gecacitinib combined with chemotherapy and venetoclax. Induction (VDCLP+V): vincristine days 1,8,15,22; daunorubicin days 1-3; cyclophosphamide days 1,15; pegaspargase day 5; prednisone days 1-28; venetoclax days 6-14 (may extend to day 21). Consolidation (CAMVT): cyclophosphamide day 1; cytarabine days 1,2,8,9; 6-MP days 1-7; vincristine day 1; ruxolitinib 100 mg twice daily days 1-28 for 2 cycles. Subsequent therapy (ruxolitinib withheld): early intensification (HVL), delayed intensification (VDLD then CAMVL), repeated once. Maintenance: alternating MM and VP + venetoclax, with continuous ruxolitinib. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age ≥14 years and ≤60 years, regardless of gender
- ECOG performance status score ≤2
- Male and female participants of childbearing potential agree to and adopt effective contraceptive measures
- Criteria for major organ function assessment: total bilirubin <1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; serum creatinine <2 × ULN; myocardial enzymes <2 × ULN; serum amylase ≤1.5 × ULN; left ventricular ejection fraction (LVEF) >45% as shown by cardiac ultrasound
Key exclusion criteria (4 listed)
- Pregnant women
- Severe uncontrolled active infections
- Mental illnesses that may hinder the completion of treatment or informed consent
- Other conditions deemed unsuitable for this study by the investigator
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 TKI targeting ABL class fusions. 40 mg every other day, continuous throughout all phases except during HD-MTX. | Drug | ABL pathway group |
| GecacitinibJAK1/2 inhibitor targeting JAK pathway alterations. 100 mg twice daily during CAMVT consolidation and maintenance. | Drug | JAK pathway group |
| VenetoclaxBCL-2 inhibitor. Escalating doses (100→200→400 mg) during induction; 400 mg during maintenance VP cycles. | Drug | ABL pathway group, JAK pathway group |
| Chemotherapy RegimenMulti-agent chemotherapy including vincristine, prednisone, daunorubicin, cyclophosphamide, pegaspargase, cytarabine, 6-MP, MTX, and dexamethasone per protocol phases. | Drug | ABL pathway group, JAK pathway group |
| BlinatumomabOptional CD19-directed BiTE antibody. 28-day continuous infusions alternating with chemotherapy. | Drug | ABL pathway group, JAK pathway group |
| CAR-T Cell TherapyOptional cellular immunotherapy preceded by fludarabine/cyclophosphamide lymphodepletion. | Procedure or surgery | ABL pathway group, JAK pathway group |
| Allogeneic HSCTStem cell transplantation for eligible patients in first complete remission. | Procedure or surgery | ABL pathway group, JAK pathway group |
Primary outcome
Rate of flow cytometry-minimal residual disease (flow-MRD) negative complete remission at 3 months after treatment initiation
Time frame: At 3 months after treatment initiation
7 secondary outcomes
Complete response (CR) rate
Time frame: At completion of induction therapy
Rate of next-generation sequencing-MRD (NGS-MRD) negative complete remission at 3 months post-treatment
Time frame: At 3 months after start of treatment
Overall survival
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 5 years
Relapse-free survival
Time frame: Up to 5 years
Cumulative incidence of relapse
Time frame: Up to 5 years
60-day mortality rate
Time frame: At 60 days
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 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Ph-Like
Active, not recruitingPhase 1
Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, Ph-Like 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 study testing Olverembatinib, Gecacitinib and Venetoclax in people with Ph-Like and Acute Lymphoblastic 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 4 inclusion and 4 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 13 May 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 flow cytometry-minimal residual disease (flow-MRD) negative complete remission at 3 months after treatment initiation (time frame: At 3 months after treatment initiation). 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 13 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.