Lymphocyte Reconstitution After Administration of Pegfilgrastim Versus Filgrastim After Peripheral Stem Cell Transplantation (PALM2)

October 31, 2016 updated by: Centre Leon Berard

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU Clermont-Ferrand, Hôpital d'Estaing
      • Lyon, France
        • Centre Léon Bérard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pegfilgrastim
Drug: Pegfilgrastim
Pegfilgrastim (Neulasta®, AMGEN Laboratories): single subcutaneous administration of Pegfilgrastim, 6 mg at day 5 (D5) after autologous stem cell transplantation
Other Names:
  • Neulasta, AMGEN Laboratories
ACTIVE_COMPARATOR: Filgrastim
Drug: Filgrastim
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)
Other Names:
  • Neupogen, AMGEN Laboratories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3 months kinetics of lymphocyte reconstitution, in the two arms
Time Frame: Lymphocyte count within the 3 months post transplantation
Lymphocyte count within the 3 months post transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 months kinetics of lymphocyte reconstitution, in the two arms
Time Frame: Lymphocyte count within the 6 months post transplantation
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)
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
Time Frame: Within the 3 months post transplantation
  1. neutrophils<0.5 G/L
  2. neutrophils<1 G/L
  3. platelets<20 G/L
  4. platelets<50 G/L
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
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
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
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
For duration of post transplantation hospital stay, an expected average of 2 weeks
Overall survival
Time Frame: Within 18 months after the first inclusion, from the date of randomization until the date of death from any cause
Within 18 months after the first inclusion, from the date of randomization until the date of death from any cause
Progression free survival
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
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
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
For duration of post transplantation hospital stay, an expected duration of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Amgen

Investigators

  • Principal Investigator: Catherine SEBBAN, MD, Centre Léon Bérard, Lyon, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET2011-010
  • 2011-A00662-39 (REGISTRY: RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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