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

NCT01541072 | Terminated

• 2 other identifiers: ET2011-0102011-A00662-39
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non Hodgkin Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 3 months kinetics of lymphocyte reconstitution, in the two arms

  Lymphocyte count within the 3 months post transplantation

Secondary Outcomes (10)

• 6 months kinetics of lymphocyte reconstitution, in the two arms

  Lymphocyte count within the 6 months post transplantation

• 6 months kinetics of lymphocyte subsets reconstitution by phenotyping, in the 2 arms

  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

  Within the 3 months post transplantation

• Number of days with temperature ≥38°, in the 2 arms

  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

  Within 3 months post transplantation

Study Arms (2)

Pegfilgrastim

EXPERIMENTAL

Drug: Pegfilgrastim

Filgrastim

ACTIVE COMPARATOR

Drug: Filgrastim

Interventions

Pegfilgrastim DRUG

Pegfilgrastim (Neulasta®, AMGEN Laboratories): single subcutaneous administration of Pegfilgrastim, 6 mg at day 5 (D5) after autologous stem cell transplantation

Also known as: Neulasta, AMGEN Laboratories

Pegfilgrastim

Filgrastim DRUG

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)

Also known as: Neupogen, AMGEN Laboratories

Filgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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

You may not qualify if:

• 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
• Impossibility to comply with protocol constraints because of geographical, psychiatric, social or family reasons
• Deprived of liberty (court judgement or administrative decision)

Sponsors & Collaborators

• Centre Leon Berard: lead
• Amgen: collaborator

Study Sites (2)

CHU Clermont-Ferrand, Hôpital d'Estaing

Clermont-Ferrand, 63000, France

Location

Centre Leon Berard

Lyon, France

Location

Related Publications (20)

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  BACKGROUND

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MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Catherine SEBBAN, MD

  Centre Leon Berard, Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

FR (2)