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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.
In this context, a prospective observatory was conducted from 2006 to 2009 in the hematology department of Prof. Michallet to assess the impact of prescribing ESAs (epoetin beta and darbepoetin) for these two distinct patient populations. A significant improvement in QOL during the six-month follow- up was observed in both groups. The effectiveness of the ESA on the red cell recovery and the reduction of red blood cell transfusions was established by comparing the evolution of Hb and transfusion needs of the population under ESA to a matched population. Moreover, no significant difference in the occurrence of thromboembolic events in survival and progression-free survival was observed between the ESA group and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | 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 | ||
| Group 2 | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Haemoglobin level from the inclusion to the final visit | At Day 1 and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fact-An questionnaire score | Patient's quality of life: Fact-An questionnaire | At Day 1 and Month 6 |
| Change in Fact-An subscales | Patient's quality of life: Fact-An subscales |
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Inclusion Criteria:
Depending on the hematologic malignancy, pre-transplant status of patients included will be the CR, very good partial or partial response.
Exclusion Criteria:
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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.
OR Patient with hematologic malignancies (ALL, AML, chronic lymphocytic leukemia, CLL, non-Hodgkin lymphoma, MDS, myeloma, myeloproliferative syndrome) and candidate for blood marrow or stem cell or placental blood transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Mauricette Michallet, Prof. | Hematology Department, Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeremy MONFRAY | Recruiting | Pierre-Bénite | France |
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| At Day 1 and Month 6 |
| Change in Fact-G questionnaire score | Patient's quality of life: Fact-G questionnaire (including physical well-being, social well-being, emotional well-being and functional well-being) | At Day 1 and Month 6 |
| Change in Fact-Anemia questionnaire score | Patient's quality of life: Fact-Anemia (including Fact-Fatigue) | At Day 1 and Month 6 |
| Change in the Number of red blood cell transfusions | Data on the erythrocyte recovery | At Month 3 and Month 6 |
| Change in the Number of platelet transfusions | Data on the platelet recovery | At Month 3 and Month 6 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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