Blinatumomab Plus Reduced-dose Chemotherapy in Treating B-ALL

NCT06742515 | Recruiting Phase 2 DMC

• 1 other identifier: IIT20240126C
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Precursor B-Cell Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; Chemotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Complete remission rate with negative minimal residual disease

  complete remission and negative MRD detected by flowcytometry

  at the end of cycle 1 and 2（each cycle is 28 days）

Secondary Outcomes (4)

• CR/CRi after Cycle 1 and 2

  at the end of cycle 1 and 2（each cycle is 28 days）

• Minimal residual disease(MRD)

  At the end of each cycle（each cycle is 28 days）

• Overall survival (OS)

  up to 5 years

• Event free survival(EFS)

  up to 5 years

Other Outcomes (1)

• Minimal residual disease (MRD)

  At the end of Cycle 1 and 2（each cycle is 28 days）

Study Arms (1)

Treatment arm

EXPERIMENTAL

Blinatumomab plus Reduced-dose Chemotherapy

Drug: Blinatumomab plus Reduced-dose Chemotherapy

Interventions

Blinatumomab plus Reduced-dose Chemotherapy DRUG

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.

Treatment arm

Eligibility Criteria

• Age: 15 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (10)

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• Lu J, Zhou H, Zhou X, Yang Y, Tong L, Miao M, Yang X, Chen S. Reduced-dose chemotherapy followed by blinatumomab in induction therapy for newly diagnosed B-cell acute lymphoblastic leukemia. Cancer Med. 2024 Mar;13(5):e7062. doi: 10.1002/cam4.7062.

  PMID: 38491815 BACKGROUND

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  PMID: 39047240 BACKGROUND

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MeSH Terms

Conditions

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jie Jin, M.D.

CONTACT

+8657187236896; jiej0503@163.com

Chenying Li, Ph.D.

CONTACT

+8657187236896; lcy890823@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)