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

February 26, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:
        • Principal Investigator:
          • Jianxiang Wang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Male or female patients aged 18 years or older
  3. CD19 expression on blasts
  4. Expected survival time greater than 3 months
  5. 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%
  6. Subject has provided written informed consent prior to any screening procedure

Exclusion Criteria:

  1. Burkitt lymphoma/leukemia
  2. Acute Leukemia of Ambiguous Lineage
  3. Clinical manifestations of active CNS or extramedullary involvement with ALL
  4. Female patients who are pregnant or breast feeding
  5. Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  6. Known HIV seropositivity
  7. 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)
  8. Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
  9. Other conditions assessed by the investigators to be inappropriate for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy and Sequential CAR-T Cells
Ph-ALL patients receiving CAR-T cells as consolidation therapy after achieving complete remission (CR) with pediatric-inspired regimen and venetoclax.
Combination product: CAR-T cells
CAR-T cells as consolidation therapy
Drug: Venetoclax
VEN
Other Names:
  • Selective inhibitor of B-cell lymphoma 2 (Bcl-2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival (DFS)
Time Frame: Up to 2 years post-registration
From CR1 to relapse, death from any cause or last follow-up
Up to 2 years post-registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years post-registration
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
Up to 5 years post-registration
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
Up to 1 year post-registration
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.
After induction (4 week)]
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.
Up to 2 years post-registration]
The rate of adverse events
Time Frame: Up to 5 years post-registration
adverse events during the treatment
Up to 5 years post-registration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Investigators

  • Principal Investigator: Jianxiang Wang, Dr, Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2024020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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