Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

December 9, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

Efficacy and Safety of Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Adult Patients With Ph-negative B-cell Acute Lymphocytic Leukemia: A Prospective, Single-arm Clinical Study

In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens. In recent years, tumor immunotherapy has demonstrated promising safety and efficacy profiles in refractory or relapsed Ph- B-ALL across a wide spectrum of adult ages. These findings suggest that broader application of immunotherapy may represent a critical strategy to improve survival in this population. In this study, we propose a regimen that combines immuno-targeted agents with low-intensity chemotherapy for newly diagnosed adult patients with Ph- B-ALL. Our primary objective is to increase the rate of measurable residual disease (MRD)-negative complete remission (CR) following induction therapy, reduce the risk of relapse, and ultimately enhance overall survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this open-label, single-arm, Phase II study, prospective clinical trial, a total of 53 Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) patients will be enrolled. The primary endpoint is measurable residual disease (MRD)-negative complete remission (CR) rate after induction therapy.

The first cycle of induction therapy is administered with Inotuzumab ozogamicin (INO), Venetoclax (VEN), and a combination of low-dose chemotherapy. The second cycle of induction therapy is Blinatumomab (Blino) plus VEN regimen. Alternatively, the first cycle of induction therapy is a combination of VEN and low-dose chemotherapy, and the second cycle of induction therapy is methotrexate (MTX) plus cytarabine (Ara-C) plus VEN regimen. Subsequent consolidation and maintenance therapy consist of low-dose chemotherapy, Blino, and VEN. Patients can receive chimeric antigen receptor T-Cell (CAR-T) Immunotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) or receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy. Study patients are scheduled for follow-up for at least 5 years after the end of maintenance therapy.

The purpose of current study is to determine the efficacy and safety of low-dose chemotherapy combined with immuno-targeted drugs in newly diagnosed adult patients with Ph- B-ALL.

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Phase 2

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 Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:

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. Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria
  2. CD22 positive tumor cells
  3. ≥18 years of age
  4. Estimated survival ≥3 months
  5. Consent and effective contraception for men and women of childbearing potential
  6. Understanding and signing of informed consent forms and agreement to comply with study requirements.

Exclusion Criteria:

  1. Burkitt lymphoma/leukemia
  2. acute leukemias of ambiguous lineage
  3. pregnant women
  4. severe uncontrolled active infection
  5. previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS)
  6. History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker implanted)
  7. New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local regulations or practices
  8. Psychiatric disorders likely to prevent the subject from completing treatment or informed consent
  9. Other conditions considered unsuitable for the study by the investigator.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-dose chemotherapy, Venetoclax combined with immuno-targeted drugs
The cycle of induction therapy is administered with immuno-targeted drugs (including Inotuzumab ozogamicin and/or Blinatumomab), a combination of low-dose chemotherapy (including vincristine, cyclophosphamide, dexamethasone, methotrexate and cytarabine) and Venetoclax (VEN).
Drug: Vincristine
Anti-tumor alkaloids
Other Names:
  • VCR
Drug: Cyclophosphamide
Alkylating agent
Other Names:
  • CTX
Drug: Prednisone
Glucocorticoids
Other Names:
  • Pred
Drug: Cytarabine
Pyrimidine antimetabolites
Other Names:
  • Ara-C
Drug: 6-mercaptopurine
Cell cycle-specific antitumor drug
Other Names:
  • 6-MP
Drug: Dexamethasone
Glucocorticoids
Other Names:
  • DEX
Drug: Methotrexate
Antifolate antineoplastic drug
Other Names:
  • MTX
Drug: Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Other Names:
  • VEN
Drug: Inotuzumab ozogamicin
A humanized monoclonal antibody-drug conjugate targeting CD22
Other Names:
  • INO
Drug: Blinatumomab
Bi-specific anti-CD19/CD3 antibodies
Other Names:
  • Blino
Experimental: low-dose chemotherapy combined with Venetoclax
The cycle of induction therapy is administered with a combination of low-dose chemotherapy and VEN.
Drug: Vincristine
Anti-tumor alkaloids
Other Names:
  • VCR
Drug: Cyclophosphamide
Alkylating agent
Other Names:
  • CTX
Drug: Prednisone
Glucocorticoids
Other Names:
  • Pred
Drug: Cytarabine
Pyrimidine antimetabolites
Other Names:
  • Ara-C
Drug: 6-mercaptopurine
Cell cycle-specific antitumor drug
Other Names:
  • 6-MP
Drug: Dexamethasone
Glucocorticoids
Other Names:
  • DEX
Drug: Methotrexate
Antifolate antineoplastic drug
Other Names:
  • MTX
Drug: Venetoclax
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Other Names:
  • VEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD-negative complete remission rate measured by flow cytometry.
Time Frame: After induction (4 week)
No immature cells were detected by flow cytometry when CR criteria were met after induction therapy.
After induction (4 week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission (CR) rate
Time Frame: an expected average of 3 months
an expected average of 3 months
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
Relapse free survival (RFS)
Time Frame: Up to 5 years post-registration
From the date of complete remission (CR) until the date of documented relapse or death due to any cause or last follow-up.
Up to 5 years post-registration
Disease-free Survival (DFS)
Time Frame: Up to 5 years post-registration
From CR1 to relapse, death from any cause or last follow-up.
Up to 5 years post-registration
Mortality
Time Frame: Day 30 and Day 60 of induction therapy initiation
Day 30 and Day 60 of induction therapy initiation

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, Institute of Hematology & Blood Diseases Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 2, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2023060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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