Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
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
1 other identifier
interventional
43
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedStudy Start
First participant enrolled
April 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
May 13, 2026
May 1, 2026
1.9 years
February 26, 2026
May 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Event-Free Survival
up to 5 years
MRD-negative CR rate by flow cytometry after induction regimen
up to 6 weeks
Secondary Outcomes (6)
Complete Remission Rate
up to 1 year
MRD-negative CR rate by flow cytometry at 12 weeks
up to 12 weeks
MRD-negative CR rate by NGS at 12 weeks
up to 12 weeks
Overall Survival (OS)
Up to 5 years
Relapse-Free Survival (RFS)
Up to 5 years
- +1 more secondary outcomes
Study Arms (2)
Chemotherapy induction Arm
EXPERIMENTALInduction 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. CAR-T Cell Therapy- optional: the third cycle. 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
EXPERIMENTALInduction 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. CAR-T Cell Therapy- optional: the third cycle. 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.
Interventions
Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol
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.
Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T.
Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.
Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.
Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.
Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.
Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Burkitt leukemia/lymphoma
- Acute leukemia of ambiguous lineage
- Pregnancy or lactation
- Severe uncontrolled active infection
- History of pancreatitis
- Uncontrolled diabetes (HbA1c \>7.5%)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 27, 2026
Study Start
April 8, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2030
Last Updated
May 13, 2026
Record last verified: 2026-05