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Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

2014-08-27 03:14:51 | BioPortfolio

Summary

RATIONALE: Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as filgrastim (G-CSF), and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.

PURPOSE: This phase II trial is studying how well giving rituximab, ICE combination chemotherapy, and G-CSF together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells.

Description

OBJECTIVES:

I. Determine the number of days of apheresis required to reach >= 5 x 106 CD34 cells/kg.

II. Determine the number of CD34 cells/kg collected in a maximum of 7 days if >= 5 x 106 CD34 cells/kg is not obtained.

OUTLINE:

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, and carboplatin and ifosfamide IV on day 3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 7 apheresis procedures until the optimal number of CD34+ cells are collected.

After completion of study treatment, patients are followed periodically for up to 12 months.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Non-Hodgkin Lymphoma

Intervention

filgrastim, plerixafor, rituximab, ifosfamide, carboplatin, etoposide, leukapheresis

Location

Fred Hutchinson Cancer Research Center
Seattle
Washington
United States
98109

Status

Not yet recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:51-0400

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Medical and Biotech [MESH] Definitions

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

An organoplatinum compound that possesses antineoplastic activity.

A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.

A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.

Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.

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