Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy (EPREX/LAM-ALLO)
|ClinicalTrials.gov Identifier: NCT02860598|
Recruitment Status : Unknown
Verified June 2016 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Anemia concerns a lot of patients with cancer and affects their quality of life (QOL). Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin level (Hb) and is a validated alternative to transfusion.
However, in hematology, if there are some specific recommendations for the use of ESAs in lymphoid pathology, there are none for myeloid disorders and in the context of autografts and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in particular interested in both indications: treatment of anemia in acute myeloid leukemia (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell source.
|Condition or disease|
|Anemia Acute Myeloid Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||104 participants|
|Official Title:||Clinical Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||June 2019|
Patient with AML de novo or secondary myelodysplasia, in Complete Remission (CR) after induction and / or salvage therapy and candidate to receive a consolidation therapy
Patient with hematologic malignancies (ALL, AML, chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma, myeloma, myeloproliferative syndrome (MDS)) and candidate for blood marrow or stem cell or placental blood transplantation.
- Change in the Haemoglobin level from the inclusion to the final visit [ Time Frame: At Day 1 and Month 6 ]
- Change in Fact-An questionnaire score [ Time Frame: At Day 1 and Month 6 ]Patient's quality of life: Fact-An questionnaire
- Change in Fact-An subscales [ Time Frame: At Day 1 and Month 6 ]Patient's quality of life: Fact-An subscales
- Change in Fact-G questionnaire score [ Time Frame: At Day 1 and Month 6 ]Patient's quality of life: Fact-G questionnaire (including physical well-being, social well-being, emotional well-being and functional well-being)
- Change in Fact-Anemia questionnaire score [ Time Frame: At Day 1 and Month 6 ]Patient's quality of life: Fact-Anemia (including Fact-Fatigue)
- Change in the Number of red blood cell transfusions [ Time Frame: At Month 3 and Month 6 ]Data on the erythrocyte recovery
- Change in the Number of platelet transfusions [ Time Frame: At Month 3 and Month 6 ]Data on the platelet recovery
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860598
|Pierre Bénite, France|
|Contact: Jeremy MONFRAY, MD-PHD +33 4 78 86 22 01 firstname.lastname@example.org|
|Study Director:||Mauricette Michallet, Prof.||Hematology Department, Hospices Civils de Lyon|