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Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05175508
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azacytidine Combined With ARTA

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days

Drug: Azacitidine
Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle 28 days
Other Names:
  • AZA

    • Drug: all trans retinoic acid
    ATRA 20mg tid by po on days 1-21 of every cycle 28 days
    Other Names:
  • ATRA

    		•
    Experimental: Azacytidine

    Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle

    Drug: Azacitidine
    Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle 28 days
    Other Names:
  • AZA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate （ORR) [6 months]

      Number of participants (responders) achieving ORR after the 6 cycle treatments，Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).

    2. Overall survival (OS) [24months]

      time from randomization to death from any cause, or last known date to be alive.

    3. Progression-free survival (PFS) [24 months]

      Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline [6 months]

      TI is when the participants who were transfusion dependent on RBC and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, the initiation of post-treatment therapy, or death, whichever is earliest.

    2. Incidence of systemic infections [6 months]

      Incidence of systemic infections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)

    • Be at least 18 years of age on day of signing informed consent

    • Not suitable for newly diagnosed patients with intensive chemotherapy

    • Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation

    • The proportion of blast cells was below 50% in bone marrow

    • Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets

    Exclusion Criteria:

    • Malignant neoplasms with other progression

    • Serious mental illness uncooperative

    • Refusal to join the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    • Principal Investigator: Han Yue, Ph.D, The First Affiliated Hospital of Soochow University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT05175508
    Other Study ID Numbers:
    • SOOCHOW-HY-2021-03
    First Posted:
    Jan 3, 2022
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by The First Affiliated Hospital of Soochow University
    acute myeloid leukemia
    myelodysplastic syndromes
    all-trans retinoic acid
    azacitidine
    Additional relevant MeSH terms:
    Hematologic Neoplasms
    Frailty
    Azacitidine
    Tretinoin

    Study Results

    No Results Posted as of Jan 3, 2022