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)

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Anemia

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 Type: Observational
• Enrollment (Anticipated): 104

Contacts and Locations

Study Locations

• France
  • Pierre Bénite, France
    • Recruiting
    • Jeremy MONFRAY
    • Contact: Jeremy MONFRAY, MD-PHD; Phone Number: +33 4 78 86 22 01; Email: jeremy.monfrey@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Haemoglobin level from the inclusion to the final visit	At Day 1 and Month 6

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Mauricette Michallet, Prof., Hematology Department, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: AML; erythropoietin; HSCT; ESAs
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Anemia
• Other Study ID Numbers: 69HCL16_0419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO