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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Pegfilgrastim (Neulasta®, AMGEN Laboratories): single subcutaneous administration of Pegfilgrastim, 6 mg at day 5 (D5) after autologous stem cell transplantation
Filgrastim (Neupogen®, AMGEN Laboratories): daily subcutaneous administration, 5µg/kg/day from day 5 (D5) after autologous stem cell transplantation until recovery from aplasia (Neutrophils \>= 0.5 G/L)
CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, France
Centre Leon Berard
Lyon, France
3 months kinetics of lymphocyte reconstitution, in the two arms
Time frame: Lymphocyte count within the 3 months post transplantation
6 months kinetics of lymphocyte reconstitution, in the two arms
Time frame: Lymphocyte count within the 6 months post transplantation
6 months kinetics of lymphocyte subsets reconstitution by phenotyping, in the 2 arms
Time frame: In the transplant and within the 6 months after transplantation (at Day 15, D30, D90, D180 after transplantation)
Average duration of neutropenia and thrombopenia, in the 2 arms
1. neutrophils\<0.5 G/L 2. neutrophils\<1 G/L 3. platelets\<20 G/L 4. platelets\<50 G/L
Time frame: Within the 3 months post transplantation
Number of days with temperature ≥38°, in the 2 arms
Time frame: For duration of post transplantation hospital stay, an expected average of 2 weeks
Number of bacterial and/or viral and/or fungal infection longer than 7 days, average duration of anti-viral, anti-fungal and antibiotic treatments, in the 2 arms
Time frame: Within 3 months post transplantation
Number of red blood cell units and platelets concentrates transfused to patient, in the 2 arms
Time frame: Within 3 months post transplantation
Evaluation of duration of Filgrastim treatment, in arm "Filgrastim"
Time frame: For duration of post transplantation hospital stay, an expected average of 2 weeks
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Overall survival
Time frame: Within 18 months after the first inclusion, from the date of randomization until the date of death from any cause
Progression free survival
The progression is measured as per 2007 Cheson international response criteria. Cheson BD et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007;25(5):579-586
Time frame: Within 18 months after yhe first inclusion, from the date of randomization until the date of the first documented progression or death from any cause, whichever came first
Average duration of febrile neutropenia (with neutrophils<0.5 G/L and temperature ≥38°), in the 2 arms
Time frame: For duration of post transplantation hospital stay, an expected duration of 2 weeks