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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

Tracking Information
First Submitted Date July 20, 2016
First Posted Date August 9, 2016
Last Update Posted Date August 9, 2016
Study Start Date December 2011
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2016)
Change in the Haemoglobin level from the inclusion to the final visit [ Time Frame: At Day 1 and Month 6 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 4, 2016)
  • Change in Fact-An questionnaire score [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-An questionnaire
  • Change in Fact-An subscales [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-An subscales
  • 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)
  • Change in Fact-Anemia questionnaire score [ Time Frame: At Day 1 and Month 6 ]
    Patient's quality of life: Fact-Anemia (including Fact-Fatigue)
  • Change in the Number of red blood cell transfusions [ Time Frame: At Month 3 and Month 6 ]
    Data on the erythrocyte recovery
  • Change in the Number of platelet transfusions [ Time Frame: At Month 3 and Month 6 ]
    Data on the platelet recovery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Anemia
  • Acute Myeloid Leukemia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 4, 2016)
104
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02860598
Other Study ID Numbers 69HCL16_0419
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Study Director: Mauricette Michallet, Prof. Hematology Department, Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date June 2016