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Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia

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ClinicalTrials.gov Identifier: NCT02844257
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.

Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.

Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.


Condition or disease
Acute Myeloid Leukaemia

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Study Type : Observational
Actual Enrollment : 1067 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2015





Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Date of last contact if alive (up to 11 months) ]
    Overall survival (OS) is defined as the time elapsed between induction chemotherapy regimen and death for any cause. Patients not known to have this event are censored on the date they were last examined


Secondary Outcome Measures :
  1. Complete remission (CR) rate [ Time Frame: up to 11 months ]
    Response to induction therapy was assessed after one or two courses of chemotherapy (Between day 28 and day 35 of each course of chemotherapy). CR was defined according to standard criteria as less than 5 % blasts in bone marrow aspirates with evidence of maturation of cell lines and restoration of peripheral blood counts.

  2. Number of blood products for each type of administration [ Time Frame: Duration of study (11 months) ]

    Transfusion of a single unit of packed red blood cell (PRBC) or one whole-blood-derived platelet concentrate (PC) or platelets collected by apheresis (PA).

    Prophylactic transfusions were consistently given at morning platelet counts of <20×109/l and haemoglobin level <80 g/l. Patients requiring platelets were transfused with PC (PCs pooled from several units with 0.7 to 1×1011 platelets/10 kg of weight). Blood products were leukoreduced through discarding the buffy coat and administered through a standard blood filter but were not irradiated or routinely leukodepleted. Only patients planned to be allografted or autografted were transfused with irradiated transfusion products.




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Ages Eligible for Study:   15 Years to 83 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute myeloid leukaemia (AML)
Criteria

Inclusion Criteria:

  • Patient > 15 years old
  • Newly diagnosed AML or post myelodysplastic syndrome (MDS)

Exclusion Criteria:

  • Patients with M3 AML of French-American-British (FAB) classification (APL, Acute Promyelocytic Leukemia)
  • World Health Organization (WHO) performance status >2; (ii)
  • Left ventricular systolic ejection fraction below the normal range
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Serum creatinine concentration > 2x ULN (Upper Limit of Normal laboratory ranges),
  • AST or ALT levels > 2.0 x upper limit of normal (ULN), except if AML-related

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844257


Locations
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France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-benite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Xavier THOMAS, MD-PhD Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02844257     History of Changes
Other Study ID Numbers: 69HCL16_0464
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by Hospices Civils de Lyon:
Acute myeloid leukaemia
Transfusion dependency
Transfusion intensity
Prognosis
Chemotherapy

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms