Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab

Last updated: November 5, 2023
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Leukemia

Platelet Disorders

Treatment

Blinatumomab

Clinical Study ID

NCT06125106
IIT20230044C-R1
  • Ages 18-70
  • All Genders

Study Summary

A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria.After induction and intensified chemotherapy, complete hematological remission wasachieved, but MRD was positive by flow cytometry;
  2. Age range from 18 to 70 years old, regardless of gender;
  3. The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
  4. Female patients of childbearing age who had a negative pregnancy test before the trialand agreed to take effective contraceptive measures during the trial until their lastvisit;
  5. Organ function is normal, and the following laboratory indicators are met within oneweek of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the CockcroftFault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), totalbilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
  6. Life expectancy greater than 8 weeks;
  7. Voluntarily sign an informed consent form to understand and comply with therequirements of the study.

Exclusion

Exclusion Criteria:

  1. Failure to achieve complete hematological remission, including residual extramedullaryinfiltration;
  2. Previously received hematopoietic stem cell transplantation;
  3. Received systemic chemotherapy within 2 weeks;
  4. Previously received treatment with Blinatumomab;
  5. Have a history of central nervous system leukemia or present with central nervoussystem leukemia;
  6. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
  7. Currently suffering from clinically significant active cardiovascular diseases, suchas uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, anygrade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardialinfarction within 6 months prior to screening;
  8. Chronic obstructive pulmonary disease with whole lung dysfunction;
  9. Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);
  10. Concomitant arteriovenous thrombosis or hypercoagulable state;
  11. Known human immunodeficiency virus (HIV) infection, or chronic infection of hepatitisB virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) beyond drug control;
  12. Pregnant or lactating women;
  13. Severe allergies to other monoclonal antibodies in the past;
  14. Those who are unable to understand, comply with the research protocol or sign aninformed consent form.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Blinatumomab
Phase: 1
Study Start date:
November 16, 2023
Estimated Completion Date:
February 01, 2026

Study Description

This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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