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Efficacy of FLAG Regimen for the Treatment of Patients With AML

Sponsor
Tianjin Medical University General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03600558
Collaborator
(none)
60
Enrollment
1
Location
19.3
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The long-term efficacy of chemotherapy in patients with acute myeloid leukemia (AML) has been significantly improved in recent years. The combination of anthracycline plus cytarabine (Ara-C) has been a standard induction regimen for patients with AML. However, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. The FLAG regimen consisting of fludarabine and high-dose cytarabine combined with G-CSF which is one of the first-line consolidation treatment options for relapsed and refractory AML. This study conducted a retrospective analysis of the intensive treatment of AML with the FLAG regimen from January 2007 to May 2018 in our hospital to evaluate the efficacy of the FLAG regimen. To provide the basis for the choice and timing of treatment for patients with AML treated with the FLAG regimen.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy of Fludarabine, Cytarabine and G-CSF (FLAG Regimen) for the Treatment of Patients With Acute Myeloid Leukemia (AML)
    Actual Study Start Date :
    Nov 21, 2018
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [3 years]

      For evaluating the FLAG effect, OS was defined from consolidation randomization to death from any cause (censored at last contact).

    Secondary Outcome Measures

    1. Relapse-free survival [2 years]

      Relapse Free Survival defined as the time from onset of FLAG treatment for AML to the first event (death or relapse).

    2. Severe adverse events [45 days]

      Severe adverse events during consolidation treatment

    3. Complete Remission Rate [2 months]

    4. Event-Free Survival Rate [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient more than 18 year old

    • De novo or secondary leukemia.

    • Treated with FLAG regimen

    Exclusion Criteria:
    • Acute promyelocytic leukemia (APL)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University General Hospital Tianjin Tianjin China 300000

    Sponsors and Collaborators

    • Tianjin Medical University General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ZhongHong Shao, head of department of Hematology, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT03600558
    Other Study ID Numbers:
    • Handong
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Apr 24, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ZhongHong Shao, head of department of Hematology, Tianjin Medical University General Hospital
    FLAG
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute

    Study Results

    No Results Posted as of Apr 24, 2020