Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

• Conditions: Anemia; Acute Myeloid Leukemia

• Registration Number: NCT02860598
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-12
• Status Verified: 2016-06
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Haemoglobin level from the inclusion to the final visit	At Day 1 and Month 6

Secondary Outcome Measures

Name	Time	Method
Change in Fact-An questionnaire score	At Day 1 and Month 6	Patient's quality of life: Fact-An questionnaire
Change in Fact-An subscales	At Day 1 and Month 6	Patient's quality of life: Fact-An subscales
Change in Fact-Anemia questionnaire score	At Day 1 and Month 6	Patient's quality of life: Fact-Anemia (including Fact-Fatigue)
Change in the Number of platelet transfusions	At Month 3 and Month 6	Data on the platelet recovery
Change in Fact-G questionnaire score	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 the Number of red blood cell transfusions	At Month 3 and Month 6	Data on the erythrocyte recovery

Trial Locations

Locations (1)

Jeremy MONFRAY; 🇫🇷 Pierre Bénite, France