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

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Brief Title

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

Official Title

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

Brief 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.
    



Study Type

Observational


Primary Outcome

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

Secondary Outcome

 Complete remission (CR) rate

Condition

Acute Myeloid Leukemia

Intervention

Transfusion

Study Arms / Comparison Groups

 Intensive chemotherapy
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

214

Start Date

March 2013

Completion Date

May 2015

Primary Completion Date

December 2014

Eligibility Criteria

        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
      

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xavier THOMAS, MD-PhD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02845232

Organization ID

69HCL16_0461


Responsible Party

Sponsor

Study Sponsor

Hospices Civils de Lyon


Study Sponsor

Xavier THOMAS, MD-PhD, Principal Investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


Verification Date

July 2016