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NCT Number: NCT05557110

Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL

Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.

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Key information

Conditions

B Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 15-65
  • Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
  • Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days)
  • ECOG score 0-3
  • Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
  • Renal function: endogenous creatinine clearance ≧30ml/min
  • Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

Exclusion criteria

  • Ph+ (BCR-ABL1 positive) ALL and known ABL class Ph-Like ALL
  • T cells ALL
  • Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
  • Acute mixed-cell leukemia
  • Central nervous system leukemia
  • HIV infection
  • HBV-DNA or HCV-RNA positive
  • Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
  • Pregnant or breastfeeding patients
  • The study patient was refused enrollment

Treatment and study plan

Blinatumomab

Drug

Reduced-intensity chemotherapy followed by Blinatumomab

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.

    Overall response rate (ORR), including complete response (CR)/ complete response rate with partial hematologic recovery (CRh)/ complete response rate with incomplete hematologic recovery (CRi).

Secondary outcomes

  1. The negative rate of minimal residual lesion (MRD)

    Time frame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.

    The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10^-4)

  2. Treatment-related SAE

    Time frame: From the beginning of induction therapy to the beginning of consolidation therapy.

    Incidence of treatment-related severe adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.

  3. Time of hematopoietic recovery

    Time frame: From the beginning of induction therapy to the beginning of consolidation therapy.

    The duration of the patient in the granulocytic deficiency and thrombocytopenia phases.

  4. Event-free survival (EFS)

    Time frame: 1 year after study completion

    The time from enrollment to the occurrence of any event, including death, progression of disease, change in treatment regimen, and occurrence of fatal or intolerable side effects.

  5. Overall survival (OS)

    Time frame: 1 year after study completion

    From the time of enrollment in the study to the time of death from any cause.

Sponsors and collaborators

Lead sponsor

Chen Suning

Other

Registry information

Official study title

A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Sep 19, 2024

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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