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NCT Number: NCT07495631

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia, Adult Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Hui Wei, MD

CONTACT

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VDCLP+V

Drug

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

2VIP

Drug

Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.

Consolidation Therapy

Drug

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

Maintenance therapy

Drug

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

Blinatumomab

Drug

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

Venetoclax

Drug

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

CNS Prophylaxis

Procedure

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

Procedure

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

Hematopoietic stem cell transplantation (HSCT)

Procedure

Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.

Primary outcomes

  1. Event-Free Survival

    Time frame: up to 5 years

  2. MRD-negative CR rate by flow cytometry after induction regimen

    Time frame: up to 6 weeks

Secondary outcomes

  1. Complete Remission Rate

    Time frame: up to 1 year

  2. MRD-negative CR rate by flow cytometry at 12 weeks

    Time frame: up to 12 weeks

  3. MRD-negative CR rate by NGS at 12 weeks

    Time frame: up to 12 weeks

  4. Overall Survival (OS)

    Time frame: Up to 5 years

  5. Relapse-Free Survival (RFS)

    Time frame: Up to 5 years

  6. Cumulative Incidence of Relapse

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Wei, Doctor

CONTACT

[email protected]

13132507161

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 27, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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