Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL

December 16, 2024 updated by: First Affiliated Hospital of Zhejiang University

Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Reduced-dose Chemotherapy in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bone marrow transplantation. The purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young Ph-negative B-ALL patients.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003
        • 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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification; 2. Age≥15 years， ≤59 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 4. Expected survival time ≥ 2 months; 5. No organ dysfunction that would restrict the use of this protocol during the screening period; 6. Understand the study and sign the informed consent form. 7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Exclusion Criteria:

  • 1. Patients with known central nervous system (CNS) involvement of ALL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.); 3. Cardiac ultrasound LVEF < 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Unable to understand or comply with the study protocol.

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: Treatment arm
Blinatumomab plus Reduced-dose Chemotherapy
Drug: Blinatumomab plus Reduced-dose Chemotherapy
Cycle 1: Reduced VCP on day1, IV and Blinatumomab for 2 weeks, IV. Cycle 2: Blinatumomab for 2 weeks, IV and Venetoclax for 2 weeks, oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate with negative minimal residual disease
Time Frame: at the end of cycle 1 and 2（each cycle is 28 days）
complete remission and negative MRD detected by flowcytometry
at the end of cycle 1 and 2（each cycle is 28 days）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 5 years
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
up to 5 years
CR/CRi after Cycle 1 and 2
Time Frame: at the end of cycle 1 and 2（each cycle is 28 days）
Blast rate lower than 5% with or without peripheral blood cell recovery
at the end of cycle 1 and 2（each cycle is 28 days）
Minimal residual disease(MRD)
Time Frame: At the end of each cycle（each cycle is 28 days）
MRD level detected by flow cytometry which value <0.1% is defined as negtive
At the end of each cycle（each cycle is 28 days）
Event free survival(EFS)
Time Frame: up to 5 years
Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease (MRD)
Time Frame: At the end of Cycle 1 and 2（each cycle is 28 days）
MRD level detected by next generation sequencing
At the end of Cycle 1 and 2（each cycle is 28 days）

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Zhejiang University

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)

October 17, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20240126C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Open in the form of original data report before December 30, 2028

IPD Sharing Supporting Information Type

  • CSR

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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