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

Acute Myeloid Leukemia Clinical Trial

— EPREX/LAM-ALLO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02860598
• Other study ID #: 69HCL16_0419
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: August 4, 2016
• Start date: December 2011
• Est. completion date: June 2019

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Anemia
• Hematologic Neoplasms
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
France	Jeremy MONFRAY	Pierre Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Haemoglobin level from the inclusion to the final visit		At Day 1 and Month 6	No
Secondary	Change in Fact-An questionnaire score	Patient's quality of life: Fact-An questionnaire	At Day 1 and Month 6	No
Secondary	Change in Fact-An subscales	Patient's quality of life: Fact-An subscales	At Day 1 and Month 6	No
Secondary	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	No
Secondary	Change in Fact-Anemia questionnaire score	Patient's quality of life: Fact-Anemia (including Fact-Fatigue)	At Day 1 and Month 6	No
Secondary	Change in the Number of red blood cell transfusions	Data on the erythrocyte recovery	At Month 3 and Month 6	No
Secondary	Change in the Number of platelet transfusions	Data on the platelet recovery	At Month 3 and Month 6	No