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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Hodgkin Lymphoma

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 months kinetics of lymphocyte reconstitution, in the two arms

Outcome Time Frame:

Lymphocyte count within the 3 months post transplantation

Safety Issue:

No

Principal Investigator

Catherine SEBBAN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard, Lyon, France

Authority:

France: The Commission nationale de l’informatique et des libertés

Study ID:

ET2011-010

NCT ID:

NCT01541072

Start Date:

February 2012

Completion Date:

August 2013

Related Keywords:

  • Non Hodgkin Lymphoma
  • Lymphoma, B-cell
  • Lymphocyte reconstitution
  • Lymphocyte subsets
  • Peripheral stem cell transplantation
  • Induction chemotherapy
  • growth factor
  • Granulocyte Colony-stimulating factor
  • Pegfilgrastim
  • Filgrastim
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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