Clinical trial NCT02860598: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Acute Myeloid Leukemia
Keywords: ESAs
erythropoietin
AML
HSCT
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in the Haemoglobin level from the inclusion to the final visit
timeFrame: At Day 1 and Month 6
Secondary outcomes:
measure: Change in Fact-An questionnaire score
timeFrame: At Day 1 and Month 6
measure: Change in Fact-An subscales
timeFrame: At Day 1 and Month 6
measure: Change in Fact-G questionnaire score
timeFrame: At Day 1 and Month 6
measure: Change in Fact-Anemia questionnaire score
timeFrame: At Day 1 and Month 6
measure: Change in the Number of red blood cell transfusions
timeFrame: At Month 3 and Month 6
measure: Change in the Number of platelet transfusions
timeFrame: At Month 3 and Month 6
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Jeremy MONFRAY
Study officials:
affiliation: Hematology Department, Hospices Civils de Lyon
name: Mauricette Michallet, Prof.
role: STUDY_DIRECTOR
References: