Acute Lymphoblastic Leukemia, AdultNCT07495631
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
A study testing VDCLP+V, 2VIP and Consolidation Therapy in people with Acute Lymphoblastic Leukemia, Adult, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- VDCLP+V, 2VIP and Consolidation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 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
- Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
- Age ≥14 years, ≤60 years
- ECOG performance status ≤2
- Adequate organ function (liver, kidney, cardiac)
- For patients of childbearing potential: use of effective contraception
- Willing and able to provide informed consent
Who cannot join
- Burkitt leukemia/lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or lactation
- Severe uncontrolled active infection
- History of pancreatitis
- Uncontrolled diabetes (HbA1c >7.5%)
Show all 11Show fewer
- Active gastrointestinal bleeding within 6 months
- Arterial/venous thrombosis within 6 months
- Known HIV positivity
- Severe psychiatric illness hindering compliance
- Any other condition deemed unsuitable 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
About this study
Official title: A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia
This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.
Read the detailed description
Adult Ph-negative ALL has inferior outcomes compared to childhood ALL. Pediatric-inspired regimens have improved survival in adolescent and young adult (AYA) patients. Venetoclax, a BCL-2 inhibitor, has shown preclinical sensitivity in Ph-negative ALL. Our center's previous IH-2022 regimen (a pediatric-inspired regimen combined with venetoclax protocol) showed promising efficacy and tolerability in adult patients.Immunotherapy is effective in ALL. This study aims to integrate immunotherapy into the pediatric-inspired backbone to optimize the regimen and improve survival outcomes.
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Being tested
- VDCLP+V, 2VIP, Consolidation Therapy, Maintenance Therapy, 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.
VDCLP+VDrug
Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.
2VIPDrug
Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.
Consolidation TherapyDrug
Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.
Maintenance TherapyDrug
Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.
BlinatumomabDrug
Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.
VenetoclaxDrug
Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol
CNS ProphylaxisProcedure or surgery
Intrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections.
Hematopoietic Stem Cell Transplantation (HSCT)Procedure or surgery
Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy induction Arm | Experimental | Induction Regimen 1 (VDCLP+V): Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.
Patients with either CD22-negative or CD22-positive B-ALL will receive this regimen.
Consolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate.
Immunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles.
Maintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months.
CNS Prophylaxis
Allogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction. Receives: Drug: VDCLP+V; Drug: Consolidation Therapy; Drug: Maintenance Therapy; Drug: Blinatumomab; Drug: Venetoclax; Procedure: CNS Prophylaxis; Procedure: Hematopoietic Stem Cell Transplantation (HSCT) |
| Immunotherapy induction Arm | Experimental | Induction Regimen 2 (2VIP): Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.
For patients with CD22-positive B-ALL (≥20% blasts), especially those aged >55 years, the 2VIP regimen is recommended.
Consolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate.
Immunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles.
Maintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months.
CNS Prophylaxis
Allogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction. Receives: Drug: 2VIP; Drug: Consolidation Therapy; Drug: Maintenance Therapy; Drug: Blinatumomab; Drug: Venetoclax; Procedure: CNS Prophylaxis; Procedure: Hematopoietic Stem Cell Transplantation (HSCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Measured: up to 5 years
MRD-negative CR rate by flow cytometry after induction regimen
Measured: up to 6 weeks
Secondary outcomes (6)
Complete Remission Rate
Measured: up to 1 year
MRD-negative CR rate by flow cytometry at 12 weeks
Measured: up to 12 weeks
MRD-negative CR rate by NGS at 12 weeks
Measured: up to 12 weeks
Overall Survival (OS)
Measured: Up to 5 years
Relapse-Free Survival (RFS)
Measured: Up to 5 years
Cumulative Incidence of Relapse
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 posted27 Mar 2026
- Study start8 Apr 2026
- 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 Acute Lymphoblastic Leukemia, AdultStudies 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
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495631
- Sponsor's protocol ID
- IIT2026003
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07495631
- Acronym / sponsor ID
- IIT2026003
- Conditions
- Acute Lymphoblastic Leukemia, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 27 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 a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.
Detailed description
Adult Ph-negative ALL has inferior outcomes compared to childhood ALL. Pediatric-inspired regimens have improved survival in adolescent and young adult (AYA) patients. Venetoclax, a BCL-2 inhibitor, has shown preclinical sensitivity in Ph-negative ALL. Our center's previous IH-2022 regimen (a pediatric-inspired regimen combined with venetoclax protocol) showed promising efficacy and tolerability in adult patients.Immunotherapy is effective in ALL. This study aims to integrate immunotherapy into the pediatric-inspired backbone to optimize the regimen and improve survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy induction Arm | Experimental | Drug: VDCLP+V, Drug: Consolidation Therapy, Drug: Maintenance Therapy, Drug: Blinatumomab, Drug: Venetoclax, Procedure: CNS Prophylaxis, Procedure: Hematopoietic Stem Cell Transplantation (HSCT)Induction Regimen 1 (VDCLP+V): Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax. Patients with either CD22-negative or CD22-positive B-ALL will receive this regimen. Consolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate. Immunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles. Maintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months. CNS Prophylaxis Allogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction. |
| Immunotherapy induction Arm | Experimental | Drug: 2VIP, Drug: Consolidation Therapy, Drug: Maintenance Therapy, Drug: Blinatumomab, Drug: Venetoclax, Procedure: CNS Prophylaxis, Procedure: Hematopoietic Stem Cell Transplantation (HSCT)Induction Regimen 2 (2VIP): Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone. For patients with CD22-positive B-ALL (≥20% blasts), especially those aged >55 years, the 2VIP regimen is recommended. Consolidation Therapy: Based on the pediatric-inspired IH-2022 protocol, including Vincristine , Daunorubicin , Cyclophosphamide, Pegaspargase , Prednisone, Dexamethasone, Cytarabine, 6-Mercaptopurine , and High-Dose Methotrexate. Immunotherapy: Blinatumomab - optional, 1 to 4 cycles, starting post-induction, alternating with chemotherapy cycles. Maintenance Therapy: Consists of a monthly MM regimen and a VP plus Venetoclax regimen every 3 months. CNS Prophylaxis Allogeneic or autologous Hematopoietic Stem Cell Transplantation is considered for high-risk patients or those with positive MRD after induction. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
- Age ≥14 years, ≤60 years
- ECOG performance status ≤2
- Adequate organ function (liver, kidney, cardiac)
- For patients of childbearing potential: use of effective contraception
Key exclusion criteria (11 listed)
- Burkitt leukemia/lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or lactation
- Severe 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 |
|---|---|---|
| VDCLP+VVincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax. | Drug | Chemotherapy induction Arm |
| 2VIPInotuzumab ozogamicin, venetoclax, vincristine, and prednisone. | Drug | Immunotherapy induction Arm |
| Consolidation TherapyIncludes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate. | Drug | Chemotherapy induction Arm, Immunotherapy induction Arm |
| Maintenance TherapyMonthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax. | Drug | Chemotherapy induction Arm, Immunotherapy induction Arm |
| BlinatumomabOptional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles. | Drug | Chemotherapy induction Arm, Immunotherapy induction Arm |
| VenetoclaxOral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol | Drug | Chemotherapy induction Arm, Immunotherapy induction Arm |
| CNS ProphylaxisIntrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections. | Procedure or surgery | Chemotherapy induction Arm, Immunotherapy induction Arm |
| Hematopoietic Stem Cell Transplantation (HSCT)Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available. | Procedure or surgery | Chemotherapy induction Arm, Immunotherapy induction Arm |
Primary outcome
Event-Free Survival
Time frame: up to 5 years
MRD-negative CR rate by flow cytometry after induction regimen
Time frame: up to 6 weeks
6 secondary outcomes
Complete Remission Rate
Time frame: up to 1 year
MRD-negative CR rate by flow cytometry at 12 weeks
Time frame: up to 12 weeks
MRD-negative CR rate by NGS at 12 weeks
Time frame: up to 12 weeks
Overall Survival (OS)
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
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 10 Aug 2026.
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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 VDCLP+V, 2VIP and Consolidation Therapy in people with Acute Lymphoblastic Leukemia, Adult, 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 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: looking for participants now, as of the sponsor's last update on 10 Aug 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, Doctor (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?
Event-Free Survival (time frame: up to 5 years). 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 10 Aug 2026.