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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Vidaza 100 milligram (mg) injection
Best Supportive Care
Sponsored by
Associazione Qol-one
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia,, Post-Remission Therapy

Eligibility Criteria

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

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:

    1. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
    2. a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
    3. a Performance Status (PS) score of > 2;
    4. uncontrolled severe infection.
  5. 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.

Sites / Locations

  • A.O. SS. Antonio e Biagio e Cesare Arrigo
  • Ospedale Riuniti
  • A.O. S. Giovanni Moscati
  • Policlinico Università di Bari
  • Ospedale L'Annunziata
  • Ospedale Ferrarotto
  • Ospedale Garibaldi
  • Ospedale Casa Sollievo della Sofferenza
  • Università degli Studi di Genova
  • IRCCS Ospedale Maggiore Policlinico
  • Ospedale Civile Spirito Santo
  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
  • Ospedale Sant'Eugenio
  • Policlinico Agostino Gemelli
  • Azienda Ospedaliera Sant'Andrea
  • IRCCS Istituto Regina Elena
  • A.O.U. San Giovanni di Dio e Ruggì D'Aragona
  • A.O.U. di Udine Centro Trapianti e Terapie Cellulari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azacitidine

Best supportive care

Arm Description

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

No drug administration

Outcomes

Primary Outcome Measures

Disease free Survival (DFS)
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

Hospitalizations
Number and length of hospitalizations in the post-remission period.
Overall Survival (OS)
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

Full Information

First Posted
December 27, 2021
Last Updated
June 7, 2023
Sponsor
Associazione Qol-one
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1. Study Identification

Unique Protocol Identification Number
NCT05188326
Brief Title
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
Official Title
A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2010 (Actual)
Primary Completion Date
September 27, 2021 (Actual)
Study Completion Date
September 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Qol-one

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia,, Post-Remission Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azacitidine
Arm Type
Experimental
Arm Description
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
Arm Title
Best supportive care
Arm Type
Placebo Comparator
Arm Description
No drug administration
Intervention Type
Drug
Intervention Name(s)
Vidaza 100 milligram (mg) injection
Other Intervention Name(s)
Vidaza
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best Supportive Care
Intervention Description
Best supportive care includes antibiotics, transfusions and fluids
Primary Outcome Measure Information:
Title
Disease free Survival (DFS)
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Hospitalizations
Description
Number and length of hospitalizations in the post-remission period.
Time Frame
5 years
Title
Overall Survival (OS)
Description
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
Time Frame
2 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 61 years or more Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents. Absence of central nervous system involvement No contraindications for intensive chemotherapy, defined as: prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; a Performance Status (PS) score of > 2; uncontrolled severe infection. Informed consent. Exclusion Criteria: Age ≤ 60 years Newly diagnosed AML with < 30% myeloid marrow blasts Previously treated AML Central nervous system involvement Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range; A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related; A PS score of > 2; Uncontrolled severe infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Natalie Oliva
Organizational Affiliation
QOL-ONE Associazione Culturale e di Ricerca
Official's Role
Study Chair
Facility Information:
Facility Name
A.O. SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
AL
Country
Italy
Facility Name
Ospedale Riuniti
City
Ancona
State/Province
AN
Country
Italy
Facility Name
A.O. S. Giovanni Moscati
City
Avellino
State/Province
AV
Country
Italy
Facility Name
Policlinico Università di Bari
City
Bari
State/Province
BA
Country
Italy
Facility Name
Ospedale L'Annunziata
City
Cosenza
State/Province
CS
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
State/Province
CT
Country
Italy
Facility Name
Ospedale Garibaldi
City
Catania
State/Province
CT
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
Country
Italy
Facility Name
Università degli Studi di Genova
City
Genova
State/Province
GE
Country
Italy
Facility Name
IRCCS Ospedale Maggiore Policlinico
City
Milano
State/Province
MI
Country
Italy
Facility Name
Ospedale Civile Spirito Santo
City
Pescara
State/Province
PE
Country
Italy
Facility Name
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89100
Country
Italy
Facility Name
Ospedale Sant'Eugenio
City
Roma
State/Province
RM
Country
Italy
Facility Name
Policlinico Agostino Gemelli
City
Roma
State/Province
RM
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Rome
State/Province
RM
Country
Italy
Facility Name
IRCCS Istituto Regina Elena
City
Rome
State/Province
RM
Country
Italy
Facility Name
A.O.U. San Giovanni di Dio e Ruggì D'Aragona
City
Salerno
State/Province
SA
Country
Italy
Facility Name
A.O.U. di Udine Centro Trapianti e Terapie Cellulari
City
Udine
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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