Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia

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.

Conditions

• Acute Lymphoblastic Leukemia, Adult

Interventions

DRUG

VDCLP+V

Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.

DRUG

2VIP

Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.

DRUG

Consolidation Therapy

Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.

DRUG

Maintenance Therapy

Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.

DRUG

Blinatumomab

Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.

DRUG

Venetoclax

Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol

PROCEDURE

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.

PROCEDURE

CAR-T Cell Therapy

Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T.

PROCEDURE

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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-08

Primary Completion

2028-03-01

Completion

2030-03-01

Countries

• China

Study Locations