ALLALL-CD22-PhNCT07921550
Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALL
A study testing Inotuzumab ozogamicin (INO), Venetoclax (VEN) and Vincristine in people with ALL, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This prospective, open-label, single-arm study evaluates whether reduced-intensity induction with venetoclax plus inotuzumab ozogamicin (2VIP) followed by one cycle of blinatumomab improves the 8-week NGS-MRD-negative complete remission rate in adolescents and adults (age 14-60 years) with newly diagnosed, untreated… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- ALL
- What is being tested?
- Inotuzumab ozogamicin (INO), Venetoclax (VEN) and Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Nov 2035
- 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
- Newly diagnosed, untreated (except prednisone/hydroxyurea) Ph-negative ALL by morphology and immunophenotype.
- CD22-positive (≥20% blasts).
- Age ≥14 and ≤60 years.
- ECOG ≤2.
- Effective contraception if of childbearing potential.
- Organ function: TBIL <1.5×ULN; AST/ALT ≤2.5×ULN; creatinine <2×ULN; myocardial enzymes <2×ULN; amylase ≤1.5×ULN; LVEF >45%.
- Written informed consent.
Who cannot join
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnancy.
- Uncontrolled active infection.
- History of pancreatitis.
- Uncontrolled diabetes (HbA1c >7.5%).
Show all 11Show fewer
- Active GI bleeding within 6 months. -
- Arterial/venous thrombosis within 6 months.
- Known HIV.
- Psychiatric disease precluding compliance.
- Other conditions judged unsuitable by the investigator.
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 Single-Arm Study of Venetoclax Combined With Inotuzumab Ozogamicin Reduced-Chemotherapy Induction Sequentially Followed by Blinatumomab in Newly Diagnosed CD22-Positive Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
This prospective, open-label, single-arm study evaluates whether reduced-intensity induction with venetoclax plus inotuzumab ozogamicin (2VIP) followed by one cycle of blinatumomab improves the 8-week NGS-MRD-negative complete remission rate in adolescents and adults (age 14-60 years) with newly diagnosed, untreated, CD22-positive, Philadelphia chromosome-negative B-cell ALL. A Simon two-stage design will enroll up to 43 evaluable patients.
- Conditions
- ALL
- Being tested
- Inotuzumab ozogamicin (INO), Venetoclax (VEN), Vincristine, Prednisone, Blinatumomab
- Keywords
- B-ALL, CD22, inotuzumab ozogamicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inotuzumab ozogamicin (INO)Drug
Inotuzumab: 1 mg d4 and d11
Venetoclax (VEN)Drug
Venetoclax ramp 100/200/400 mg d6-14
VincristineDrug
Vincristine 1.4 mg/m² (max 2 mg) d1,8
PrednisoneDrug
Prednisone 1 mg/kg/d d1-14.
BlinatumomabBiological
Blinatumomab 8.75 μg d1-8 then 28 μg d9-28.
| Study group | Role | What they receive |
|---|---|---|
| 2VIP induction followed by blinatumomab, then pediatric-inspired chemo | Experimental | Induction 2VIP: Inotuzumab 1 mg d4 and d11; Vincristine 1.4 mg/m² (max 2 mg) d1,8; Venetoclax ramp 100/200/400 mg d6-14; Prednisone 1 mg/kg/d d1-14. Immunologic consolidation: Blinatumomab 8.75 μg d1-8 then 28 μg d9-28. Subsequent CAMVL / HD-MTX-based early intensification / VDLD delayed intensification / maintenance (female 2.5 y, male 3 y). Optional additional 2VIP or Blinatumomab per protocol Receives: Drug: Inotuzumab ozogamicin (INO); Drug: Venetoclax (VEN); Drug: Vincristine; Drug: Prednisone; Biological: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-week NGS-MRD-negative complete remission (CR_MRD-) rate
Proportion of evaluable patients achieving CR (or CRi/CRp counted as CR per protocol) with NGS (IG/TR clonotype) MRD negativity at week 8. Time frame: 8 weeks from start of protocol therapy.
Measured: up to 8 weeks
Secondary outcomes (8)
2-week NGS-MRD-negative CR rate
Measured: up to 2 weeks
12-week flow-cytometry MRD-negative CR rate
Measured: up to 12 weeks
Event-free survival (EFS)
Measured: Up to 5 years
Overall survival (OS)
Measured: Up to 5 years
Disease-free survival (DFS)
Measured: Up to 5 years
Relapse-free survival (RFS)
Measured: Up to 5 years
Cumulative incidence of relapse
Measured: Up to 5 years
Early mortality at 4 weeks and 8 weeks
Measured: Up to 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion30 Nov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921550
- Sponsor's protocol ID
- ALL-CD22-Ph-negative-2026
- Acronym
- ALL-CD22-Ph
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pending PI confirmation
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Study of Venetoclax Combined With Inotuzumab Ozogamicin Reduced-Chemotherapy Induction Sequentially Followed by Blinatumomab in Newly Diagnosed CD22-Positive Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07921550
- Acronym / sponsor ID
- ALL-CD22-Ph / ALL-CD22-Ph-negative-2026
- Conditions
- ALL
- Keywords
- B-ALL, CD22, inotuzumab ozogamicin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Nov 2035 (estimated)
- First posted
- 6 Nov 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 prospective, open-label, single-arm study evaluates whether reduced-intensity induction with venetoclax plus inotuzumab ozogamicin (2VIP) followed by one cycle of blinatumomab improves the 8-week NGS-MRD-negative complete remission rate in adolescents and adults (age 14-60 years) with newly diagnosed, untreated, CD22-positive, Philadelphia chromosome-negative B-cell ALL. A Simon two-stage design will enroll up to 43 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2VIP induction followed by blinatumomab, then pediatric-inspired chemo | Experimental | Drug: Inotuzumab ozogamicin (INO), Drug: Venetoclax (VEN), Drug: Vincristine, Drug: Prednisone, Biological: BlinatumomabInduction 2VIP: Inotuzumab 1 mg d4 and d11; Vincristine 1.4 mg/m² (max 2 mg) d1,8; Venetoclax ramp 100/200/400 mg d6-14; Prednisone 1 mg/kg/d d1-14. Immunologic consolidation: Blinatumomab 8.75 μg d1-8 then 28 μg d9-28. Subsequent CAMVL / HD-MTX-based early intensification / VDLD delayed intensification / maintenance (female 2.5 y, male 3 y). Optional additional 2VIP or Blinatumomab per protocol |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Newly diagnosed, untreated (except prednisone/hydroxyurea) Ph-negative ALL by morphology and immunophenotype.
- CD22-positive (≥20% blasts).
- Age ≥14 and ≤60 years.
- ECOG ≤2.
- Effective contraception if of childbearing potential.
Key exclusion criteria (11 listed)
- Burkitt lymphoma/leukemia.
- Acute leukemia of ambiguous lineage.
- Pregnancy.
- Uncontrolled active infection.
- History of pancreatitis.
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 (INO)Inotuzumab: 1 mg d4 and d11 | Drug | 2VIP induction followed by blinatumomab, then pediatric-inspired chemo |
| Venetoclax (VEN)Venetoclax ramp 100/200/400 mg d6-14 | Drug | 2VIP induction followed by blinatumomab, then pediatric-inspired chemo |
| VincristineVincristine 1.4 mg/m² (max 2 mg) d1,8 | Drug | 2VIP induction followed by blinatumomab, then pediatric-inspired chemo |
| PrednisonePrednisone 1 mg/kg/d d1-14. | Drug | 2VIP induction followed by blinatumomab, then pediatric-inspired chemo |
| BlinatumomabBlinatumomab 8.75 μg d1-8 then 28 μg d9-28. | Biological | 2VIP induction followed by blinatumomab, then pediatric-inspired chemo |
Primary outcome
8-week NGS-MRD-negative complete remission (CR_MRD-) rate
Time frame: up to 8 weeks
Proportion of evaluable patients achieving CR (or CRi/CRp counted as CR per protocol) with NGS (IG/TR clonotype) MRD negativity at week 8. Time frame: 8 weeks from start of protocol therapy.
8 secondary outcomes
2-week NGS-MRD-negative CR rate
Time frame: up to 2 weeks
12-week flow-cytometry MRD-negative CR rate
Time frame: up to 12 weeks
Event-free survival (EFS)
Time frame: Up to 5 years
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
Cumulative incidence of relapse
Time frame: Up to 5 years
Early mortality at 4 weeks and 8 weeks
Time frame: Up to 4 weeks and 8 weeks
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Pending PI confirmation
Related trials for ALL
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
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 study testing Inotuzumab ozogamicin (INO), Venetoclax (VEN) and Vincristine in people with 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 11 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 6 Nov 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.
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, Professor (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?
8-week NGS-MRD-negative complete remission (CR_MRD-) rate (time frame: up to 8 weeks). 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 6 Nov 2026.