Non Hodgkin Lymphoma Clinical Trial
Official title:
Lymphocyte Reconstitution in a Randomized Study After Administration of Pegfilgrastim Versus Filgrastim in Patients With B-cell Non-Hodgkin Lymphoma Treated With High-dose Chemotherapy and Autologous Peripheral Stem Cell Transplantation
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.
High dose chemotherapy with autologous peripheral stem cell transplantation is a standard
consolidation treatment used in patients with non-Hodgkin lymphoma, in first or second line
of treatment. This procedure is associated with prolonged neutropenia and considerable
morbidity. Different guidelines have recommended the use of growth factor after peripheral
stem cell transplantation.Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF)
resulting from the modification of Filgrastim by chemical addition of a polyethylene
glycol(PEG) moiety which increases its half-life by decreasing its renal clearance. Then, a
single injection substitutes several Filgrastim injections. The trial "PALM" realized by our
team has shown, between these 2 molecules, an equivalent efficacy on the duration of
chemotherapy-induced febrile neutropenia in patients treated for lymphoma or myeloma. This
trial has also shown that Pegfilgrastim is a cost-effectiveness dominant strategy.
Some studies have shown that a rapid lymphocyte reconstitution after stem cell
transplantation is associated with better overall survival and progression-free survival.
In the present PALM2 study, the investigators want to describe the kinetics of different
lymphocyte subsets reconstitution within 3 and 6 months after transplantation, in patients
with B-cell malignant non-Hodgkin lymphoma, in first or second-line chemotherapy and first
autologous transplantation. The investigators will assess the kinetics of reconstitution for
T-lymphocytes (Naïve T-lymphocytes, regulatory T-cells and memory T-cells), B-lymphocytes
(transitional B cells), cytotoxic T-cells and natural killer T-cells, dendritic cells. A
preliminary phase to this assessment will consist in estimate intra-center variability of
lymphocyte phenotyping.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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