Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2022 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). 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.
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
Key Details
Gender
All
Age Range
14 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-03-01
Completion Date
2030-03-01
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
VDCLP+V
Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.
2VIP
Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.
Consolidation Therapy
Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.
Maintenance Therapy
Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.
Blinatumomab
Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.
Venetoclax
Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol
CNS Prophylaxis
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.
CAR-T Cell Therapy
Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T.
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.