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Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

Primary Purpose

Acute Lymphocytic Leukemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Inotuzumab ozogamicin
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
  2. Age ≥18 years
  3. ECOG PS score: 0 to 2

  4. Functions of the main organs are normal, if the following criteria are met:

    1. Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
    2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
    3. Serum creatinine ≤ 1.5 × ULN
    4. Creatinine clearance ≥ 30 ml/min
  5. No active or co-existing malignancy with a life expectancy of less than 12 months
  6. Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.

Exclusion Criteria:

  1. Mixed lineage leukemia
  2. Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)

  3. Patients with severe and / or uncontrolled diseases, such as:

    1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
    2. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
    3. Known to be human immunodeficiency virus positive (HIV+)
    4. Active and uncontrolled disease/infection as judged by the treating physician
    5. Active central nervous system (CNS) or extramedullary disease
    6. Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
  4. Pregnant or nursing women
  5. Unable or unwilling to sign the consent form
  6. Monoclonal antibodies therapy within 2 weeks before study entry
  7. Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
  8. Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
  9. Patients in other situations who are evaluated by the investigator to be ineligible

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Inotuzumab Ozogamicin

    Arm Description

    Each subject will be treated with Inotuzumab Ozogamicin

    Outcomes

    Primary Outcome Measures

    MRD negativity rate within the first treatment cycle
    MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission

    Secondary Outcome Measures

    Complete MRD response rates
    Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
    Duration of MRD negativity rate
    The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
    MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
    The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
    Relapse-free Survival (RFS)
    RFS is defined as the time from the date of CR until the date of relapse or death
    Overall Survival (OS)
    OS is defined as the time from enrollment to date of death due to any cause.

    Full Information

    First Posted
    March 29, 2022
    Last Updated
    July 11, 2022
    Sponsor
    Institute of Hematology & Blood Diseases Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05456698
    Brief Title
    Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy
    Official Title
    Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Hematology & Blood Diseases Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Lymphocytic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    31 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inotuzumab Ozogamicin
    Arm Type
    Experimental
    Arm Description
    Each subject will be treated with Inotuzumab Ozogamicin
    Intervention Type
    Drug
    Intervention Name(s)
    Inotuzumab ozogamicin
    Other Intervention Name(s)
    CMC-544
    Intervention Description
    Patients who achieved CR/CRi had their InO dose at 1.5mg/m2 per cycle (28days/cycle), with 0.5mg/m2 administered on days 1, 8, and 15. Patients received treatment for up to two cycles in the absence of disease progression or unacceptable toxicity.
    Primary Outcome Measure Information:
    Title
    MRD negativity rate within the first treatment cycle
    Description
    MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
    Time Frame
    At the end of Cycle 1 (each cycle is 28 days)
    Secondary Outcome Measure Information:
    Title
    Complete MRD response rates
    Description
    Complete MRD response is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
    Time Frame
    At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
    Title
    Duration of MRD negativity rate
    Description
    The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status.
    Time Frame
    From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days)
    Title
    MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively
    Description
    The variation of MRD level from baseline to post cycle 1, cycle 2, respectively
    Time Frame
    From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days)
    Title
    Relapse-free Survival (RFS)
    Description
    RFS is defined as the time from the date of CR until the date of relapse or death
    Time Frame
    Up to 5 years from enrollment
    Title
    Overall Survival (OS)
    Description
    OS is defined as the time from enrollment to date of death due to any cause.
    Time Frame
    Up to 5 years from enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry. Age ≥18 years ECOG PS score: 0 to 2 Functions of the main organs are normal, if the following criteria are met: Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN Creatinine clearance ≥ 30 ml/min No active or co-existing malignancy with a life expectancy of less than 12 months Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed. Exclusion Criteria: Mixed lineage leukemia Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS) Patients with severe and / or uncontrolled diseases, such as: Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis Known to be human immunodeficiency virus positive (HIV+) Active and uncontrolled disease/infection as judged by the treating physician Active central nervous system (CNS) or extramedullary disease Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study Pregnant or nursing women Unable or unwilling to sign the consent form Monoclonal antibodies therapy within 2 weeks before study entry Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO Patients in other situations who are evaluated by the investigator to be ineligible

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

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