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NCT Number: NCT06481241

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.

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Key information

Conditions

Philadelphia Chromosome Negative ALL 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Location status: Recruiting

Location contact

Jianxiang Wang, Dr.

CONTACT

[email protected]

86-22-23909120

Jianxiang Wang, Dr.

PRINCIPAL_INVESTIGATOR

About this study

The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation domain of 4-1BB, and the infusion dose was 1×10^6/kg CAR+ cells in a single infusion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
  • Male or female patients aged 18 years or older
  • CD19 expression on blasts
  • Expected survival time greater than 3 months
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%
  • Subject has provided written informed consent prior to any screening procedure

Exclusion criteria

  • Burkitt lymphoma/leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Clinical manifestations of active CNS or extramedullary involvement with ALL
  • Female patients who are pregnant or breast feeding
  • Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • Known HIV seropositivity
  • Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)
  • Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • Other conditions assessed by the investigators to be inappropriate for this study

Treatment and study plan

CAR-T cells

Combination Product

CAR-T cells as consolidation therapy

Venetoclax

Drug

VEN

Other names: Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

Primary outcomes

  1. Disease-free Survival (DFS)

    Time frame: Up to 2 years post-registration

    From CR1 to relapse, death from any cause or last follow-up

Secondary outcomes

  1. MRD-negative complete remission rate measured by flow cytometry.

    Time frame: After induction (4 week)]

    No blasts were detected by flow cytometry when CR criteria were met after induction therapy.

  2. Overall survival (OS)

    Time frame: Up to 5 years post-registration

    From the date of registration to the date of death resulting from any cause.

  3. Event-free survival (EFS)

    Time frame: Up to 5 years post-registration

    From the date of registration to the date of induction failure, relapse, death from any cause, or last follow-up

  4. MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements

    Time frame: Up to 1 year post-registration

    No clonal IG/TR rearrangements were detected by NGS

  5. Cumulative incidence of relapse (CIR)

    Time frame: Up to 2 years post-registration]

    Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk.

  6. The rate of adverse events

    Time frame: Up to 5 years post-registration

    adverse events during the treatment

Other outcomes

  1. Interim analysis index

    Time frame: From enrollment to 12 months

    It is planned to conduct one interim analysis in the study: when the median follow-up date of patients reaches 1 year, the Independent Data Monitoring Committee (IDMC) will perform a hypothesis test by comparing the 1-year disease-free survival (DFS) rate (the primary endpoint) of the trial group with the 70% 1-year DFS rate of the historical control. The alpha (α) spending function will be calculated using the O'Brien-Fleming method. If the DFS rate of the trial group is found to be significantly superior to that of the historical control in the interim analysis and achieves statistical significance at the nominal significance level αk, the trial may be terminated early. If no statistically significant difference is observed between the two groups in the interim analysis, the investigators will decide whether to continue the trial based on practical circumstances.

Study contacts

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

Jianxiang Wang, Dr

CONTACT

[email protected]

86-22-23608451

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 1, 2024
Registry last updated
Mar 2, 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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