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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

Status: Recruiting

Location: See location...

Intervention Type: Drug, Procedure

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 14

Maximum Age: 60

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

China

Blood Diseases Hospital

RECRUITING

Tianjin

Contact Information

Primary

Hui Wei, Doctor

weihui@ihcams.ac.cn

13132507161

Time Frame

Start Date: 2026-04-08

Estimated Completion Date: 2030-03-01

Participants

Target number of participants: 43

Treatments

Experimental: Chemotherapy induction Arm

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.~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.

Experimental: Immunotherapy induction Arm

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.~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.

Related Therapeutic Areas

Acute Lymphoblastic Leukemia (ALL)

Leukemia

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