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Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia

Primary Purpose

Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GM-CSF priming
Placebo
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

Eligibility Criteria

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

Inclusion Criteria:

  • All patients with acute non-lymphocytic leukemia are eligible for the study.

Exclusion Criteria:

  • N/A

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    GM-CSF priming

    Arm Description

    Outcomes

    Primary Outcome Measures

    complete remission rates

    Secondary Outcome Measures

    Full Information

    First Posted
    June 19, 2020
    Last Updated
    June 20, 2023
    Sponsor
    Eastern Cooperative Oncology Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04446052
    Brief Title
    Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia
    Official Title
    Phase III Study Priming With rhu_GM-CSF and of Three Induction Regimens in Adult Patients (55 and Over) With Acute Non-Lymphocytic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 21, 1993 (Actual)
    Primary Completion Date
    July 10, 2002 (Actual)
    Study Completion Date
    July 10, 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eastern Cooperative Oncology Group

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Phase III Study of Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF) and ofThree Induction Regimens in Adult Patients (Over 55) with Acute Non-Lymphocytic Leukemia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    362 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    GM-CSF priming
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    GM-CSF priming
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    complete remission rates
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    56 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients with acute non-lymphocytic leukemia are eligible for the study. Exclusion Criteria: N/A

    12. IPD Sharing Statement

    Learn more about this trial

    Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia

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