Ph- Acute Lymphoblastic Leukemia (Ph-ALL)Phase 2Ph- ALL-2026NCT07643103
Immuno-Targeted Therapy Plus Low-Dose Chemotherapy for Newly Diagnosed Adult Ph-Negative B-ALL: A Prospective Umbrella Trial
A Phase 2 study testing Inotuzumab Ozogamicin (IO), Venetoclax and Blinatumomab in people with Ph- Acute Lymphoblastic Leukemia (Ph-ALL), run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-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?
- Inotuzumab Ozogamicin (IO), Venetoclax and Blinatumomab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 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
- Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.
- CD22-positive expression on tumor cells (CD22 ≥20%).
- Expected survival ≥3 months.
- Sexually active men and women of childbearing potential must agree to use effective contraception.
- Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures.
Who cannot join
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnant women.
- Severe, uncontrolled active infections.
- History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS).
- History of clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), or sinus node dysfunction or high-grade atrioventricular (AV) block with chronic bradycardia, unless a permanent pacemaker has been implanted.
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- Uncontrolled active hepatitis B or hepatitis C infection, or known HIV seropositivity. HIV testing may be required according to local regulations or standards.
- Psychiatric disorders that may impair the subject's ability to complete treatment or provide informed consent.
- Any other conditions deemed by the investigator to render the subject unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Umbrella Clinical Trial of Immuno-Targeted Agents Combined With Low-Dose Chemotherapy for Newly Diagnosed Adult Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.
The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.
- Being tested
- Inotuzumab Ozogamicin (IO), Venetoclax, Blinatumomab, CD19-directed chimeric antigen receptor (CAR-T) T cells, Vincristine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inotuzumab Ozogamicin (IO)Drug
Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy.
VenetoclaxDrug
BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis.
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.
VincristineDrug
A vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells.
CyclophosphamideDrug
An alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells.
DexamethasoneDrug
A synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden.
MethotrexateDrug
A folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells.
Cytarabine (Ara-C)Drug
A pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation.
PrednisoneDrug
A glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy.
Mercaptopurine 50 mgDrug
A purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation.
| Study group | Role | What they receive |
|---|---|---|
| Immuno-Targeted Therapy Plus Low-Dose Chemotherapy | Experimental | Adult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL) receive frontline treatment with immuno-targeted agents, a BCL2 inhibitor, and low-dose chemotherapy. Induction therapy includes inotuzumab ozogamicin, venetoclax, vincristine, cyclophosphamide, and dexamethasone. Subsequent treatment is adapted according to measurable residual disease (MRD) response, antigen expression profile, and clinical condition, and may include blinatumomab-based immunotherapy, venetoclax-containing chemotherapy, CD19-directed CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients proceed to protocol-defined maintenance therapy. Receives: Drug: Inotuzumab Ozogamicin (IO); Drug: Venetoclax; Drug: Blinatumomab; Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Dexamethasone; Drug: Methotrexate; Drug: Cytarabine (Ara-C); Drug: Prednisone; Drug: Mercaptopurine 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Cytometric MRD-Negative Complete Remission Rate
Proportion of patients achieving complete remission (CR) with negative measurable residual disease (MRD) assessed by multiparameter flow cytometry after completion of induction therapy.
Measured: At the end of induction therapy (approximately 1 month after treatment initiation)
Secondary outcomes (8)
Next-Generation Sequencing (NGS)-MRD Negative Remission Rate
Proportion of patients achieving MRD-negative remission assessed by immune repertoire sequencing.
Measured: Within 3 months after treatment initiation
Best MRD Clearance Rate
Proportion of patients achieving the deepest MRD response during the first 3 months of treatment as assessed by flow cytometry, quantitative PCR, or immune repertoire sequencing.
Measured: Within 3 months after treatment initiation
Overall Survival (OS)
Time from study enrollment to death from any cause.
Measured: Up to 5 years
Disease-Free Survival (DFS)
Time from achievement of complete remission to relapse or death from any cause.
Measured: Up to 5 years
Relapse-Free Survival (RFS)
Time from achievement of MRD-negative remission to hematologic relapse or death.
Measured: Up to 5 years
30-Day Mortality
Proportion of patients who die from any cause within 30 days after treatment initiation.
Measured: 30 days
60-Day Mortality
Proportion of patients who die from any cause within 60 days after treatment initiation.
Measured: 60 days
Incidence of Adverse Events
Frequency, severity, and type of adverse events graded according to the National Cancer
Measured: From treatment initiation through completion of study treatment, 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 posted11 Jun 2026
- Study start12 Jun 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
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643103
- Sponsor's protocol ID
- IIT2026063
- Other IDs
- IIT2026063-EC-1
- Acronym
- Ph- ALL-2026
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Umbrella Clinical Trial of Immuno-Targeted Agents Combined With Low-Dose Chemotherapy for Newly Diagnosed Adult Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07643103
- Acronym / sponsor ID
- Ph- ALL-2026 / IIT2026063
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 12 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 11 Jun 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 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.
The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuno-Targeted Therapy Plus Low-Dose Chemotherapy | Experimental | Drug: Inotuzumab Ozogamicin (IO), Drug: Venetoclax, Drug: Blinatumomab, Biological: CD19-directed chimeric antigen receptor (CAR-T) T cells, Drug: Vincristine, Drug: Cyclophosphamide, Drug: Dexamethasone, Drug: Methotrexate, Drug: Cytarabine (Ara-C), Drug: Prednisone, Drug: Mercaptopurine 50 mgAdult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL) receive frontline treatment with immuno-targeted agents, a BCL2 inhibitor, and low-dose chemotherapy. Induction therapy includes inotuzumab ozogamicin, venetoclax, vincristine, cyclophosphamide, and dexamethasone. Subsequent treatment is adapted according to measurable residual disease (MRD) response, antigen expression profile, and clinical condition, and may include blinatumomab-based immunotherapy, venetoclax-containing chemotherapy, CD19-directed CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients proceed to protocol-defined maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria.
- CD22-positive expression on tumor cells (CD22 ≥20%).
- Expected survival ≥3 months.
- Sexually active men and women of childbearing potential must agree to use effective contraception.
- Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures.
Key exclusion criteria (9 listed)
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnant women.
- Severe, uncontrolled active infections.
- History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS).
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 Ozogamicin (IO)Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| VenetoclaxBCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| BlinatumomabCD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| 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 | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| VincristineA vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| CyclophosphamideAn alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| DexamethasoneA synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| MethotrexateA folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| Cytarabine (Ara-C)A pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| PrednisoneA glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
| Mercaptopurine 50 mgA purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation. | Drug | Immuno-Targeted Therapy Plus Low-Dose Chemotherapy |
Primary outcome
Flow Cytometric MRD-Negative Complete Remission Rate
Time frame: At the end of induction therapy (approximately 1 month after treatment initiation)
Proportion of patients achieving complete remission (CR) with negative measurable residual disease (MRD) assessed by multiparameter flow cytometry after completion of induction therapy.
8 secondary outcomes
Next-Generation Sequencing (NGS)-MRD Negative Remission Rate
Time frame: Within 3 months after treatment initiation
Best MRD Clearance Rate
Time frame: Within 3 months after treatment initiation
Overall Survival (OS)
Time frame: Up to 5 years
Disease-Free Survival (DFS)
Time frame: Up to 5 years
Relapse-Free Survival (RFS)
Time frame: Up to 5 years
30-Day Mortality
Time frame: 30 days
60-Day Mortality
Time frame: 60 days
Incidence of Adverse Events
Time frame: From treatment initiation through completion of study treatment, 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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inotuzumab Ozogamicin (IO), Venetoclax and Blinatumomab in people with Ph- Acute Lymphoblastic Leukemia (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 5 inclusion and 9 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 11 Jun 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?
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?
Flow Cytometric MRD-Negative Complete Remission Rate (time frame: At the end of induction therapy (approximately 1 month 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 11 Jun 2026.