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Lenograstim

Adjuvants, Immunologic

Immunologic Factors

pegfilgrastim

filgrastim

The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.

A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma

A Randomised, Multi-Centre, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Non-Hodgkin's Lymphoma

Amgen

Global Development Leader

Hodgkin Disease

Hodgkin Lymphoma

Pegfilgrastim 6 mg given once for PBPC mobilization

Pegfilgrastim 12 mg given once for PBPC mobilization

Filgrastim given daily for PBPC mobilization

pegfilgrastim 12 mg

pegfilgrastim 6 mg

This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.

This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting.

Pegfilgrastim PBPC Mobilization Study

Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma	NCT00117455	Non-Hodgkin's L...	pegfilgrastim filgrastim	18 Years -	Amgen
Pegfilgrastim PBPC Mobilization Study	NCT00066092	Lymphoma Hodgkin's Lymph... Non-Hodgkin's L... Hematology Oncology	pegfilgrastim 1... filgrastim pegfilgrastim 6...	18 Years -	Amgen
A Study of Peripheral Blood Progenitor Cell (PBPC) Mobilisation by Chemotherapy With Pegfilgrastim or Filgrastim in Subjects With Non-Hodgkin's Lymphoma	NCT00117455	Non-Hodgkin's L...	pegfilgrastim filgrastim	18 Years -	Amgen
Pegfilgrastim PBPC Mobilization Study	NCT00066092	Lymphoma Hodgkin's Lymph... Non-Hodgkin's L... Hematology Oncology	pegfilgrastim 1... filgrastim pegfilgrastim 6...	18 Years -	Amgen

Spots Global Cancer Trial Database for pbpc transplant