RecruitingRecruiting
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
NCT07495631 · Institute of Hematology & Blood Diseases Hospital, China
In plain English
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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
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 43 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2026-04-08
Estimated completion: 2030-03-01
Last updated: 2026-05-13
Interventions
Drug: VDCLP+VDrug: 2VIPDrug: Consolidation TherapyDrug: Maintenance TherapyDrug: BlinatumomabDrug: VenetoclaxProcedure: CNS ProphylaxisProcedure: CAR-T Cell TherapyProcedure: Hematopoietic Stem Cell Transplantation (HSCT)
Primary outcomes
- • Event-Free Survival (up to 5 years)
- • MRD-negative CR rate by flow cytometry after induction regimen (up to 6 weeks)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · other
Contacts & investigators
ContactHui Wei, Doctor · contact · weihui@ihcams.ac.cn · 13132507161
All locations (1)
Blood Diseases HospitalRecruiting
Tianjin, Tianjin Municipality, China