Lymphocyte Reconstitution After Administration of Pegfilgrastim Versus Filgrastim After Peripheral Stem Cell Transplantation

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the kinetics of lymphocyte subsets reconstitution after growth factor administration, Pegfilgrastim versus Filgrastim in patients with B-cell malignant non-Hodgkin lymphoma treated with high-dose chemotherapy and autologous peripheral stem cell transplantation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: Amgen
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Patients with B-cell NHL, except Burkitt Lymphoma and primary brain lymphoma, as first-line or second-line therapy, with planed BICNU, etoposide, aracytine and melphalan (BEAM) chemotherapy after pre-inclusion.

• Minimum one mobilization with G-CSF, G-CSF and endoxan or mozobil

• Minimum one cytapheresis with CD34>2 millions CD34/kg for stem cell transplantation

• Patients hospitalized in the investigational center throughout the procedure and until recovery from aplasia (neutrophils> 0.5 G/L)

• Mandatory affiliation with a health insurance system

• Subjects must provide written informed consent prior to performance of study-specific assessments

Exclusion Criteria:

• Patients already treated with intensive chemotherapy and autologous stem cell transplantation

• Total irradiation exposure (patients with partial irradiation exposure can be included in the study)

• Intolerance to one of the two studied growth factors, or hypersensitivity to one of their components

• Patients with neutropenia (neutrophils <1.2 G/L) or thrombopenia (platelets < 100 G/L) before intensive chemotherapy

• Acquired immune deficiency syndrome, seropositivity

• Pregnant or lactating women (pregnancy test, for women of childbearing potential, should be negative, in blood or urine, at inclusion time)

• Impossibility to comply with protocol constraints because of geographical, psychiatric, social or family reasons

• Deprived of liberty (court judgement or administrative decision)