Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

Sponsor
Associazione Qol-one (Other)
Overall Status
Completed
CT.gov ID
NCT05188326
Collaborator
(none)
54
18
2
130
3
0

Study Details

Study Description

Brief Summary

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vidaza 100 milligram (mg) injection
  • Other: Best Supportive Care
Phase 3

Detailed Description

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
Actual Study Start Date :
Nov 28, 2010
Actual Primary Completion Date :
Sep 27, 2021
Actual Study Completion Date :
Sep 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azacitidine

Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months

Drug: Vidaza 100 milligram (mg) injection
1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission.
Other Names:
  • Vidaza
  • Placebo Comparator: Best supportive care

    No drug administration

    Other: Best Supportive Care
    Best supportive care includes antibiotics, transfusions and fluids

    Outcome Measures

    Primary Outcome Measures

    1. Disease free Survival (DFS) [2 and 5 years]

      Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.

    Secondary Outcome Measures

    1. Hospitalizations [5 years]

      Number and length of hospitalizations in the post-remission period.

    2. Overall Survival (OS) [2 and 5 years]

      Overall survival (OS) at 2 and 5 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    61 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age 61 years or more

    2. Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.

    3. Absence of central nervous system involvement

    4. No contraindications for intensive chemotherapy, defined as:

    5. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;

    6. a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;

    7. a Performance Status (PS) score of > 2;

    8. uncontrolled severe infection.

    9. Informed consent.

    Exclusion Criteria:
    1. Age ≤ 60 years

    2. Newly diagnosed AML with < 30% myeloid marrow blasts

    3. Previously treated AML

    4. Central nervous system involvement

    5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;

    6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;

    7. A PS score of > 2;

    8. Uncontrolled severe infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.O. SS. Antonio e Biagio e Cesare Arrigo Alessandria AL Italy
    2 Ospedale Riuniti Ancona AN Italy
    3 A.O. S. Giovanni Moscati Avellino AV Italy
    4 Policlinico Università di Bari Bari BA Italy
    5 Ospedale L'Annunziata Cosenza CS Italy
    6 Ospedale Ferrarotto Catania CT Italy
    7 Ospedale Garibaldi Catania CT Italy
    8 Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo FG Italy
    9 Università degli Studi di Genova Genova GE Italy
    10 IRCCS Ospedale Maggiore Policlinico Milano MI Italy
    11 Ospedale Civile Spirito Santo Pescara PE Italy
    12 Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli Reggio Calabria RC Italy 89100
    13 Ospedale Sant'Eugenio Roma RM Italy
    14 Policlinico Agostino Gemelli Roma RM Italy
    15 Azienda Ospedaliera Sant'Andrea Rome RM Italy
    16 IRCCS Istituto Regina Elena Rome RM Italy
    17 A.O.U. San Giovanni di Dio e Ruggì D'Aragona Salerno SA Italy
    18 A.O.U. di Udine Centro Trapianti e Terapie Cellulari Udine Italy

    Sponsors and Collaborators

    • Associazione Qol-one

    Investigators

    • Study Chair: Esther Natalie Oliva, QOL-ONE Associazione Culturale e di Ricerca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Associazione Qol-one
    ClinicalTrials.gov Identifier:
    NCT05188326
    Other Study ID Numbers:
    • QOLESS-AZA-AMLE
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    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
    Keywords provided by Associazione Qol-one
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2022