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Acute Myeloid LeukemiaNCT02845232

Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

An observational study of Acute Myeloid Leukemia, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Transfusion
How many people
214 participants
Where
1 siteFrance
Study dates
Mar 2013to May 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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Three groups of elderly patients aged 70 years or older, with AML. First group: 68 patients receiving a combination of intermediate-dose cytarabine and an anthracycline. One patient with acute promyelocytic leukaemia (APL) also received all-trans retinoic acid (ATRA). The second study group comprised 70 patients who were treated on frontline by lower-intensity treatments [LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)]. The last study group comprises 76 patients: 31 patients received supportive care, while 36 patients also received hydroxyurea and 9 patients received 6-mercaptopurine.

Who may be able to join

  • Age ≥ 70 years old
  • AML according to the World Health Organization (WHO) criteria (% of blasts ≥ 20% in bone marrow aspiration).
  • All FAB subtypes.
  • Any type of AML (de novo or secondary)
  • All participants to clinical trials gave their written informed consent

Who cannot join

  • Have an Eastern Cooperative Oncology Group (ECOG) score ≥2
  • Active uncontrolled infection

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

Other trials in France

About this study

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.

The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.

Being tested
Transfusion
Keywords
Acute myeloid leukemia, Therapy, Blood transfusion, Cost-effectiveness, Prognosis
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.

  • TransfusionOther

    The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.

Study groups in NCT02845232
Study groupRoleWhat they receive
Intensive chemotherapyFirst group: 68 patients receiving a combination of intermediate-dose cytarabine and an anthracycline. One patient with acute promyelocytic leukaemia (APL) also received all-trans retinoic acid (ATRA).
Receives: Other: Transfusion
Lower-intensity treatmentsThe second study group comprised 70 patients who were treated on frontline by lower-intensity treatments [LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)]. Patients received LD-AraC 20 mg once or twice daily (according to physician'schoice) by subcutaneous injection for 10 consecutive days. Azacitidine was given at the dose of 75 mg/m2/day for 7 consecutive days by sc injection. Decitabine was administered by intravenous route once daily at 20 mg/m2 for 5 consecutive days. Tipifarnib was given at 600 mg administered orally twice daily for 21 consecutive days in 4-week cycles. ATRA was given at 45 mg/m2until CR achievement followed by maintenance combining 6-mercaptopurine with methotrexate.
Receives: Other: Transfusion
Best Supportive CareThe last study group comprises 76 patients: 31 patients received supportive care, while 36 patients also received hydroxyurea and 9 patients received 6-mercaptopurine.
Receives: Other: Transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival

    The cost-effectiveness of blood product transfusion was determined among initial treatment subgroups: patients receiving intensive chemotherapy, patients receiving low-intensity treatments, and patients treated only by BSC.

    Measured: From starting treatment to death from any cause (up to 21 months)

Secondary outcomes (2)

  1. Complete remission (CR) rate

    Complete remission (CR) was defined by bone marrow aspiration, which was required to consist of more than 50% normal cellularity with evidence of trilineage maturation and less than 5% bone marrow blasts, no evidence of extramedullary disease, and regeneration of the peripheral neutrophil count to 1.0 × 109/L and the platelet count to 100 × 109/L. The persistence of myelodysplastic features did not exclude the diagnosis of CR.

    Measured: Duration of study (Month 21)

  2. Number of blood product transfusions per patient

    Decisions concerning transfusion indications were based on institutional policy and the clinical judgment of treating physicians. Transfusion practice was consistent during the period of study. Prophylactic transfusions were consistently given at morning platelet counts of < 20 ×109/L and haemoglobin level < 80 g/L. Protocol Blood products were leukoreduced through discarding the buffy coat and administered through a standard 140 to 170 µm blood filter but were not irradiated

    Measured: Duration of study (Month 21)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startMar 2013
  3. Primary completionDec 2014
  4. Study completionMay 2015

Resources

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
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845232
Sponsor's protocol ID
69HCL16_0461
Status last verified
Jul 2016
First submitted
20 Jul 2016
Last updated
27 Jul 2016
Results posted
No
Data monitoring committee
No

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 5 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 27 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?

Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival (time frame: From starting treatment to death from any cause (up to 21 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845232.

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 27 Jul 2016.

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