Acute Myeloid LeukemiaPhase 3NCT05188326
Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients
A Phase 3 study testing Vidaza 100 milligram (mg) injection in people with Acute Myeloid Leukemia, run by Associazione Qol-one at 18 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Vidaza 100 milligram (mg) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 18 sitesItaly
- Study dates
- 28 Nov 2010to 27 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- a Performance Status (PS) score of > 2;
- uncontrolled severe infection.
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, AL
Ospedale Riuniti
Ancona, AN
A.O. S. Giovanni Moscati
Avellino, AV
Policlinico Università di Bari
Bari, BA
Ospedale Ferrarotto
Catania, CT
Ospedale Garibaldi
Catania, CT
Ospedale L'Annunziata
Cosenza, CS
Università degli Studi di Genova
Genova, GE
IRCCS Ospedale Maggiore Policlinico
Milan, MI
Ospedale Civile Spirito Santo
Pescara, PE
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, RC, 89100
Ospedale Sant'Eugenio
Roma, RM
Policlinico Agostino Gemelli
Roma, RM
Azienda Ospedaliera Sant'Andrea
Rome, RM
IRCCS Istituto Regina Elena
Rome, RM
A.O.U. San Giovanni di Dio e Ruggì D'Aragona
Salerno, SA
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG
A.O.U. di Udine Centro Trapianti e Terapie Cellulari
Udine
About this study
Official title: A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
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.
Read the 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
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Vidaza 100 milligram (mg) injection, Best Supportive Care
- Keywords
- Acute Myeloid Leukemia,, Post-Remission Therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vidaza 100 milligram (mg) injectionDrug
Also called Vidaza
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.
Best Supportive CareOther
Best supportive care includes antibiotics, transfusions and fluids
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine | Experimental | 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 Receives: Drug: Vidaza 100 milligram (mg) injection |
| Best supportive care | Placebo comparator | No drug administration Receives: Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Hospitalizations
Number and length of hospitalizations in the post-remission period.
Measured: 5 years
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
Measured: 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start28 Nov 2010
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Qol-one
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther Natalie Oliva, Study chair, QOL-ONE Associazione Culturale e di Ricerca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188326
- Sponsor's protocol ID
- QOLESS-AZA-AMLE
- Status last verified
- Jun 2023
- First submitted
- 27 Dec 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients
- ClinicalTrials.gov ID
- NCT05188326
- Acronym / sponsor ID
- QOLESS-AZA-AMLE
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia,, Post-Remission Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Associazione Qol-oneUniversity, hospital or other
- Study start
- 28 Nov 2010 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azacitidine | Experimental | Drug: Vidaza 100 milligram (mg) injectionVidaza 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 |
| Best supportive care | Placebo comparator | Other: Best Supportive CareNo drug administration |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Informed consent.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vidaza 100 milligram (mg) injectionAlso: Vidaza1st 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. | Drug | Azacitidine |
| Best Supportive CareBest supportive care includes antibiotics, transfusions and fluids | Other | Best supportive care |
Primary outcome
Disease free Survival (DFS)
Time frame: 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.
2 secondary outcomes
Hospitalizations
Time frame: 5 years
Overall Survival (OS)
Time frame: 2 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Natalie Oliva study chair
QOL-ONE Associazione Culturale e di Ricerca
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vidaza 100 milligram (mg) injection in people with Acute Myeloid Leukemia, run by Associazione Qol-one at 18 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free Survival (DFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.