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NCT Number: NCT06075238

Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • B-ALL patients with history of relapse, or MRD positive in the last bone marrow examination before allo-HSCT;
  • Age ≥16 years old and ≤ 65 years old when signing informed consent Form (ICF);
  • KPS > 60 or ECOG 0-2;
  • The expected survival time is more than 3 months;
  • Complete remission (CR) after allo-HSCT with either myeloablative or non-myeloablative conditioning regimen determined by the investigator;
  • Reach the standard of hematopoietic reconstitution (neutrophil count

≥ 0.5×10^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within 45 days after transplantation;

  • No central nervous system involvement or clinical symptoms after transplantation;
  • Those who have no serious functional damage to important organs of the body;
  • Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
  • Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.

Exclusion criteria

  • Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
  • Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
  • Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;
  • Poor graft function (PGF) occurred after allo-HSCT;
  • Combined with other malignant tumors and require treatment;
  • Active GVHD;
  • Have a history of allergy to Chidamide;
  • Pregnant or lactating females;
  • Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
  • Patients with active chronic hepatitis B or active hepatitis C;
  • History of prolonged QT syndrome;
  • Patients considered by other researchers to be unsuitable for this study

Treatment and study plan

Blinatumomab

Drug

The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 2 years

    Progression free survival of this group of patients at the end of 2 year

  2. 100 day adverse events (AE)

    Time frame: Day +100

    non-hematologic adverse events

Secondary outcomes

  1. Non-relapse mortality (NRM)

    Time frame: 6 months

    Non-relapse mortality of this group of patients at the end of 6 month

  2. Relapse rate

    Time frame: 2 years

    Relapse rate of this group of patients at the end of 2 year

  3. Overall survival (OS)

    Time frame: 2 years

    Overall survival of this group of patients at the end of 2 year

  4. Cumulative incidence of acute graft versus host disease (aGVHD)

    Time frame: Day +100

    Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100

  5. Cumulative incidence of chronic graft versus host disease (cGVHD)

    Time frame: 2 years

    Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Ji, MD

CONTACT

[email protected]

86-28-85422373

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

Blinatumomab Prevents the Recurrence of Relapsed or Refractory Acute Lymphoblastic Leukemia After Allogeneic Hematopoietic Stem-cell Transplantation: A Prospective, Singlecentered, Single-arm, Phase II Clinical Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

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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