Acute Myeloid LeukemiaNCT02844218
Effect of Age on Treatment Decision-Making in Elderly Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly patients, owing to comorbidities, the greater possibility of other hematopoietic disorders, and a biologically poor risk prognosis. Read more about this study
- Who is it for?
- Ages 70 to 79 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Age of patient
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Feb 2015
- Phase
- Observational
- 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 70 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Acute myeloid leukemia (AML)
Who may be able to join
- Are at least 70 years of age
- Have a diagnosis of AML according to World Health Organization (WHO) classification
- Provide signed, written informed consent
Who cannot join
- Patients with acute promyelocytic leukemia
- Have an ECOG score ≥2
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69310
About this study
Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly patients, owing to comorbidities, the greater possibility of other hematopoietic disorders, and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy, administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for this patient population. This approach improved survival compared with supportive care (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that the results of intensive chemotherapy in elderly patients remain poor. Although complete remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term survival has been poor. Furthermore, most clinical trials have only enrolled patients with an adequate performance status (PS).
Prognostic models have been developed from clinical trial data to predict the outcomes for older patients. However; each model relies on chronologic age. Age is a surrogate measure for both changes in tumor biology and patient characteristics. Understanding which patients are likely to benefit from intensive therapies versus low-intensity therapies or supportive care is critical. The definition of "fit" to undergo intensive induction therapy has not been established, and the therapeutic choice is mainly determined by physician and patient decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that could have an improved side effect profile and, in some cases, bioavailability might offer future improvement for this patient population. In this setting, the investigators have tended to consider, since 2007, patients aged ≥70 years as potential candidates for alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they presented in good physical condition.
The investigators goal was to determine whether age ≥ 70 years could represent a useful and simple cut off for treatment decision-making in clinical practice and whether low-intensity therapy could be an alternative therapeutic approach to intensive chemotherapy even for patients aged ≥ 70 years who were theoretically "fit" (WHO /ECOG/ PS of ≤ 2).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Age of patient
- Keywords
- Acute myeloid leukemia, Chemotherapy, Low-intensity therapy, Older patients, Prognosis, Supportive care
- 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.
Age of patientOther
- Historical Comparison Between Patients Aged 60 to 69 and Patients Aged ≥ 70 Years Treated With Intensive Chemotherapy.
- Comparison between Intensive Chemotherapy and Low-Intensity Treatments in Patients Aged ≥70 Years.
- Improvement of Treatments Over Time
- Overall Survival (OS) of patients aged ≥ 70 Years during3 study periods. Period 1, from 1985 to 1999, during which all patients with acute Myeloid Leukemia received an intensive chemotherapy regimen at the University Hospital. Period 2, from 2000 to 2006, during which all patients received an Intensive Chemotherapy regimen, Improved Supportive Care and follow-Up protocol at the University Hospital. Period 3, From 2007 to 2014, during Which patients received Improved Supportive Care and follow-up protocol at the University Hospital and "Personalized" Therapy (Intensive Chemotherapy or Low-Dose Intensity Treatment)
| Study group | Role | What they receive |
|---|---|---|
| Intensive chemotherapy group | Group 1: Patients' age ≥ 70 years treated from 1985 to 1999 with intensive induction chemotherapy. Receives: Other: Age of patient | |
| Lower intensity treatment group | Group 2: patients treated from 2000 to 2006 with intensive chemotherapy plus improved supportive care and a follow-up protocol systematically performed at the university hospital. Receives: Other: Age of patient | |
| personalized treatment group | Group 3: patients who had received, starting in 2007, more "personalized" treatment with either intensive chemotherapy or lower-intensity therapy determined by the clinical judgment of the treating physician. Receives: Other: Age of patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was the main endpoint for this analysis. The event for OS was death, and patients were censored at the date of last contact, if alive.
Measured: Date of last contact if alive (up to 11 months)
Secondary outcomes (2)
Complete remission rate (CR)
A CR was defined according to standard criteria as < 5% blasts in bone marrow aspirates with evidence of maturation of cell lines and restoration of the peripheral blood counts.
Measured: Date of last contact if alive or death (up to 11 months)
First Relapse
Hematologic relapse was considered when > 5% blasts were seen in 2 bone marrow aspirates obtained at a 15-day interval.
Measured: Duration of the study (11 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionFeb 2015
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier THOMAS, MD-PhD, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844218
- Sponsor's protocol ID
- 69HCL16_0463
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on Treatment Decision-Making in Elderly Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02844218
- Acronym / sponsor ID
- 69HCL16_0463
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, Chemotherapy, Low-intensity therapy, Older patients, Prognosis, Supportive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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.
Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly patients, owing to comorbidities, the greater possibility of other hematopoietic disorders, and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy, administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for this patient population. This approach improved survival compared with supportive care (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that the results of intensive chemotherapy in elderly patients remain poor. Although complete remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term survival has been poor. Furthermore, most clinical trials have only enrolled patients with an adequate performance status (PS).
Prognostic models have been developed from clinical trial data to predict the outcomes for older patients. However; each model relies on chronologic age. Age is a surrogate measure for both changes in tumor biology and patient characteristics. Understanding which patients are likely to benefit from intensive therapies versus low-intensity therapies or supportive care is critical. The definition of "fit" to undergo intensive induction therapy has not been established, and the therapeutic choice is mainly determined by physician and patient decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that could have an improved side effect profile and, in some cases, bioavailability might offer future improvement for this patient population. In this setting, the investigators have tended to consider, since 2007, patients aged ≥70 years as potential candidates for alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they presented in good physical condition.
The investigators goal was to determine whether age ≥ 70 years could represent a useful and simple cut off for treatment decision-making in clinical practice and whether low-intensity therapy could be an alternative therapeutic approach to intensive chemotherapy even for patients aged ≥ 70 years who were theoretically "fit" (WHO /ECOG/ PS of ≤ 2).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive chemotherapy group | – | Other: Age of patientGroup 1: Patients' age ≥ 70 years treated from 1985 to 1999 with intensive induction chemotherapy. |
| Lower intensity treatment group | – | Other: Age of patientGroup 2: patients treated from 2000 to 2006 with intensive chemotherapy plus improved supportive care and a follow-up protocol systematically performed at the university hospital. |
| personalized treatment group | – | Other: Age of patientGroup 3: patients who had received, starting in 2007, more "personalized" treatment with either intensive chemotherapy or lower-intensity therapy determined by the clinical judgment of the treating physician. |
Who may qualify
- Ages
- 70 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Acute myeloid leukemia (AML)
Key inclusion criteria (3 listed)
- Are at least 70 years of age
- Have a diagnosis of AML according to World Health Organization (WHO) classification
- Provide signed, written informed consent
Key exclusion criteria (2 listed)
- Patients with acute promyelocytic leukemia
- Have an ECOG score ≥2
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 |
|---|---|---|
| Age of patient* Historical Comparison Between Patients Aged 60 to 69 and Patients Aged ≥ 70 Years Treated With Intensive Chemotherapy. * Comparison between Intensive Chemotherapy and Low-Intensity Treatments in Patients Aged ≥70 Years. * Improvement of Treatments Over Time * Overall Survival (OS) of patients aged ≥ 70 Years during3 study periods. Period 1, from 1985 to 1999, during which all patients with acute Myeloid Leukemia received an intensive chemotherapy regimen at the University Hospital. Period 2, from 2000 to 2006, during which all patients received an Intensive Chemotherapy regimen, Improved Supportive Care and follow-Up protocol at the University Hospital. Period 3, From 2007 to 2014, during Which patients received Improved Supportive Care and follow-up protocol at the University Hospital and "Personalized" Therapy (Intensive Chemotherapy or Low-Dose Intensity Treatment) | Other | Intensive chemotherapy group, Lower intensity treatment group, personalized treatment group |
Primary outcome
Overall survival (OS)
Time frame: Date of last contact if alive (up to 11 months)
OS was the main endpoint for this analysis. The event for OS was death, and patients were censored at the date of last contact, if alive.
2 secondary outcomes
Complete remission rate (CR)
Time frame: Date of last contact if alive or death (up to 11 months)
First Relapse
Time frame: Duration of the study (11 months)
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 26 Jul 2016.
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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.
Xavier THOMAS, MD-PhD principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 2 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Overall survival (OS) (time frame: Date of last contact if alive (up to 11 months)). 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 26 Jul 2016.