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
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%)
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- 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.
- 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
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- 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