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| Sponsors and Collaborators: |
Centre Leon Berard UBET (Centre Léon Bérard): design, implementation, data analysis and reporting. Amgen |
|---|---|
| Information provided by: | Centre Leon Berard |
| ClinicalTrials.gov Identifier: | NCT00794261 |
Purpose
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.
Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.
The number of patients required in this multicentric and prospective study is 150 (13 participating centers).
This is a phase II, controlled, randomized, non comparative and open-label multicentric study.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Myeloma |
Drug: Injection of Pegfilgrastim Drug: Injection of Filgrastim |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation |
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Pegfilgrastim: Experimental
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
|
Drug: Injection of Pegfilgrastim
Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
|
|
Filgrastim: Active Comparator
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)
|
Drug: Injection of Filgrastim
Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN > 0.5 G/L)
|
High-dose chemotherapy with autologous peripheral stem cell (PSC) transplantation is a standard consolidation treatment for the initial management of patients with myeloma treated with high-dose Melphalan, or patients with certain lymphomas or with chemosensitive relapses of Hodgkin's lymphoma (HL) or malignant non Hodgkin's lymphoma (MNHL). This procedure is associated with prolonged neutropenia and considerable morbidity. Many randomized trials have tested post-graft administration of granulocyte growth factors (granulocyte colony stimulating Factor: G-CSF) or granulocyte-monocyte growth factors (granulocyte macrophage colony stimulating Factor: GM-CSF). All have shown a reduction of neutropenia and shorter hospital stays on G-CSF or GM-CSF treatment. Different guidelines have recommended the use of growth factors after autologous stem cell transplantation. The effectiveness of growth factor treatment would be identical, whether given immediately after PSC transplantation or delayed until D5 or D7.
Pegfilgrastim is a growth factor resulting from the modification of Filgrastim by addition of a polyethylene glycol (PEG) moiety, which increases its half-life by decreasing its renal clearance. Thus, one injection is equivalent to several Filgrastim injections. Studies of Pegfilgrastim or Filgrastim efficacy on the duration of chemotherapy-induced neutropenia in patients with breast cancer or with non-small cell lung cancer or LMNH have produced equivalent results.
In haematology, Pegfilgrastim has been used for PSC mobilization. Six studies evaluating the efficacy of Pegfilgrastim compared to other G-CSF after autologous hematopoietic PSC transplantation in patients with myeloma and lymphomas have shown equivalent results. A superiority of Pegfilgrastim over other G-CSF has even been reported (though in only one randomized small-scale study).
A randomized phase II study evaluating Pegfilgrastim efficacy and tolerance in lymphoma or myeloma patients receiving PSC transplantation appears necessary to confirm or refute the potential clinical interest of the drug.
On the day of autologous PSC transplantation (D0) the patients will be randomly assigned to receive one or the other treatment strategy.
NB: Patients will receive support care, antibiotic treatments and transfusion procedures specific to each participating centre.
They will be followed-up according to recommendations for the management of this type of patients. No additional examination is planned.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Treatment with high-dose chemotherapy before inclusion
Exclusion Criteria:
Contacts and Locations| Contact: Anne LEFRANC | +33 478 78 59 46 | lefranc@lyon.fnclcc.fr |
| France | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69008 | |
| Contact: Catherine SEBBAN, MD +33 478 78 28 07 sebban@lyon.fnclcc.fr | |
| Sub-Investigator: Pierre BIRON, MD | |
| Sub-Investigator: Florence LACHENAL, MD | |
| Sub-Investigator: Hervé GHESQUIERS, MD | |
| Principal Investigator: Catherine SEBBAN, MD | |
| Institut Gustave Roussy | Not yet recruiting |
| Villejuif, France, 94805 | |
| Contact: Jean-Henri BOURHIS, MD +33 142 11 53 82 jhb@igr.fr | |
| Principal Investigator: Jean-Henri BOURHIS, MD | |
| Sub-Investigator: Claire FABRE, MD | |
| Sub-Investigator: Vincent RIBRAG, MD | |
| Centre Hospitalier Lyon Sud | Not yet recruiting |
| Pierre Bénite, France, 69495 | |
| Contact: Daniel ESPINOUSE, MD +33 478 86 43 04 daniel.espinouse@chu-lyon.fr | |
| Principal Investigator: Daniel ESPINOUSE, MD | |
| Sub-Investigator: Bertrand COIFFIER, MD | |
| Sub-Investigator: Gilles SALLES, MD | |
| CHU Tours - Hôpital Bretonneau | Not yet recruiting |
| Tours, France, 37000 | |
| Contact: Séverine LISSANDRE, MD +33 247 47 37 12 severinelissandre@yahoo.fr | |
| Principal Investigator: Séverine LISSANDRE, MD | |
| Sub-Investigator: Philippe COLOMBAT, MD | |
| Sub-Investigator: Lofti BENBOUBKER, MD | |
| CHU Nantes | Not yet recruiting |
| Nantes, France, 44000 | |
| Contact: Thomas GASTINNE, MD +33 240 08 32 71 thomas.gastinne@chu-nantes.fr | |
| Principal Investigator: Thomas GASTINNE, MD | |
| Sub-Investigator: Jean Luc HAROUSSEAU, MD | |
| Sub-Investigator: Philippe MOREAU, MD | |
| Sub-Investigator: Steven LE GOUILL, MD | |
| Sub-Investigator: Nicolas BLIN, MD | |
| Sub-Investigator: Mohamad MOHTY, MD | |
| Sub-Investigator: Patrice CHEVALIER, MD | |
| Sub-Investigator: Jacques DELAUNAY, MD | |
| Sub-Investigator: Sameh AYARI, MD | |
| Sub-Investigator: Thierry GUILLAUME, MD | |
| Hopital Edouard Herriot | Not yet recruiting |
| Lyon, France, 69008 | |
| Contact: Mauricette MICHALLET, MD +33 472 11 74 02 mauricette.michallet@chu-lyon.fr | |
| Principal Investigator: Mauricette MICHALLET, MD | |
| Sub-Investigator: Quoc Hung LE, MD | |
| Sub-Investigator: Jacques TRONCY, MD | |
| Sub-Investigator: Franck NICOLINI, MD | |
| Sub-Investigator: Xavier Georges THOMAS, MD | |
| Sub-Investigator: Giovanna CANNAS, MD | |
| Sub-Investigator: Nicolae CLAUDIU, MD | |
| Hôpital Lapeyronnie | Not yet recruiting |
| Montpellier, France, 34295 | |
| Contact: Philippe QUITTET, MD +33 467 33 83 62 p-quittet@chu-montpellier.fr | |
| Principal Investigator: Plilippe QUITTET, MD | |
| Sub-Investigator: Guillaume CARTRON, MD | |
| Sub-Investigator: Jean François ROSSI, MD | |
| CHU Brest | Not yet recruiting |
| Brest, France, 29609 | |
| Contact: Jean Christophe IANOTTO, MD jean-christophe.ianotto@chu-brest.fr | |
| Principal Investigator: Jean Christophe IANOTTO, MD | |
| Sub-Investigator: Gaëlle GUILLERM, MD | |
| Centre Henri Becquerel | Not yet recruiting |
| ROUEN, France, 76038 | |
| Contact: Fabrice JARDIN, MD +33 232 08 24 65 fabrice.jardin@rouen.fnclcc.fr | |
| Principal Investigator: Fabrice JARDIN, MD | |
| Sub-Investigator: Hervé TILLY, MD | |
| Sub-Investigator: Aspasia STAMATOULLAS-BASTARD, MD | |
| Sub-Investigator: Nathalie CONTENTIN, MD | |
| Sub-Investigator: Pascal LENAIN, MD | |
| Sub-Investigator: Stéphane LEPRETRE, MD | |
| Sub-Investigator: Alexia THANNBERGER, MD | |
| Sub-Investigator: Nathalie CARDINAEL, MD | |
| Sub-Investigator: Marie Laure FONTOURA, MD | |
| CHU Angers | Not yet recruiting |
| Angers, France, 49000 | |
| Contact: Norbert IFRAH, MD +33 241 35 44 72 noifrah@chu-angers.fr | |
| Principal Investigator: Norbert IFRAH, MD | |
| Sub-Investigator: Mathilde HUNAULT, MD | |
| CHU Toulouse - Hôpital Purpam | Not yet recruiting |
| Toulouse, France, 31000 | |
| Contact: Anne HUYN, MD +33 561 77 76 05 huynh.a@chu-toulouse.fr | |
| Principal Investigator: Anne HUYN, MD | |
| Sub-Investigator: Murielle ROUSSEL, MD | |
| Sub-Investigator: Michel ATTAL, MD | |
| Sub-Investigator: Christian RECHER, MD | |
| Principal Investigator: | Catherine SEBBAN, MD | Centre Léon Bérard, LYON |
More Information
| Responsible Party: | Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE ( Zora ABDELBOST ) |
| Study ID Numbers: | PALM, ET2007 - 113 |
| Study First Received: | November 19, 2008 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00794261 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Myeloma lymphoma high-dose chemotherapy PSC infusion, autologous neutropenia |
thrombocytopenia hospital stay infection Autologous PSC transplantation for patients with lymphoma or myeloma treated with high-dose chemotherapy |
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Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma |
Neutropenia Lymphatic Diseases Hemorrhagic Disorders Thrombocytopenia Multiple myeloma Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
|
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |
