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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)

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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Anemia Acute Myeloid Leukemia

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.

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
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


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.



Primary Outcome Measures :
  1. Change in the Haemoglobin level from the inclusion to the final visit [ Time Frame: At Day 1 and Month 6 ]

Secondary Outcome Measures :
  1. Change in Fact-An questionnaire score [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-An questionnaire

  2. Change in Fact-An subscales [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-An subscales

  3. 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)

  4. Change in Fact-Anemia questionnaire score [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-Anemia (including Fact-Fatigue)

  5. Change in the Number of red blood cell transfusions [ Time Frame: At Month 3 and Month 6 ]
    Data on the erythrocyte recovery

  6. Change in the Number of platelet transfusions [ Time Frame: At Month 3 and Month 6 ]
    Data on the platelet recovery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860598


Locations
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France
Jeremy MONFRAY Recruiting
Pierre Bénite, France
Contact: Jeremy MONFRAY, MD-PHD    +33 4 78 86 22 01    jeremy.monfrey@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Mauricette Michallet, Prof. Hematology Department, Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02860598     History of Changes
Other Study ID Numbers: 69HCL16_0419
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
ESAs
erythropoietin
AML
HSCT
Additional relevant MeSH terms:
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Hematologic Neoplasms
Anemia
Neoplasms
Hematologic Diseases
Neoplasms by Site
Epoetin Alfa
Hematinics