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

NCT ID: NCT02860598

Last Updated: 2016-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2019-06-30

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.

Conditions

Anemia; Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauricette Michallet, Prof.

Role: STUDY_DIRECTOR

Hematology Department, Hospices Civils de Lyon

Locations

Jeremy MONFRAY

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Jeremy MONFRAY, MD-PHD

Role: primary

jeremy.monfrey@chu-lyon.fr

+33 4 78 86 22 01

Other Identifiers

69HCL16_0419

Identifier Type: -

Identifier Source: org_study_id