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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845232
• Other study ID #: 69HCL16_0461
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 22, 2016
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Have an Eastern Cooperative Oncology Group (ECOG) score =2

• Active uncontrolled infection

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Transfusion
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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet	Pierre-benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From starting treatment to death from any cause (up to 21 months)	No
Secondary	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.	Duration of study (Month 21)	No
Secondary	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	Duration of study (Month 21)	No