RecruitingNot ApplicableNCT07495631

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

43 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia, Adult

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

Min Age: 14 YearsMax Age: 60 Years

Inclusion Criteria6

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 Criteria11

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

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Interventions

DRUGVDCLP+V

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

DRUG2VIP

Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.

DRUGConsolidation Therapy

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

DRUGMaintenance Therapy

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

DRUGBlinatumomab

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

DRUGVenetoclax

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

PROCEDURECNS 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.

PROCEDURECAR-T Cell Therapy

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

PROCEDUREHematopoietic 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.