Clinical Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in the Haemoglobin level from the inclusion to the final visit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •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.
- •Depending on the hematologic malignancy, pre-transplant status of patients included will be the CR, very good partial or partial response.
- •Patient with anemia (Hb blood level ≤ 110g / l) induced by consolidation chemotherapy or allograft conditioning (myeloablative or non-myeloablative).
- •Patient eligible according to the investigator, to treatment with ESA (evaluation by the investigator of the benefice- risk ratio).
- •Written informed consent.
排除标准
- •Contraindication to epoetin alfa or epoetin zeta.
- •Patient not able to receive adequate antithrombotic prophylaxis.
- •Patients who received ESA therapy within 3 weeks prior to inclusion.
- •non French-speaking patient
- •Patient participating or having participated to a clinical trial evaluating a novel molecule in the 30 days before inclusion.
- •pregnant or nursing, woman or woman of childbearing potential without effective contraception
结局指标
主要结局
Change in the Haemoglobin level from the inclusion to the final visit
时间窗: At Day 1 and Month 6
次要结局
- Change in Fact-An subscales(At Day 1 and Month 6)
- Change in Fact-Anemia questionnaire score(At Day 1 and Month 6)
- Change in the Number of platelet transfusions(At Month 3 and Month 6)
- Change in Fact-An questionnaire score(At Day 1 and Month 6)
- Change in Fact-G questionnaire score(At Day 1 and Month 6)
- Change in the Number of red blood cell transfusions(At Month 3 and Month 6)