Bendamustine Hydrochloride, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma
Summary
RATIONALE: Giving chemotherapy, such as bendamustine hydrochloride and dexamethasone, before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored.
PURPOSE: This phase II trial is studying how well giving bendamustine hydrochloride, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma.
Description
PRIMARY OBJECTIVES:
I. To estimate the frequency of bendamustine combined with GCSF and dexamethasone to successfully mobilize PBSCs (as determined by collecting a minimum of 2 x 10^6 CD34+/kg).
SECONDARY OBJECTIVES:
I. To evaluate the response rate to bendamustine by diagnosis using established disease-specific response criteria.
II. To examine the number of apheresis cycles required to collect a minimum of 2 x 10^6 CD34+ cells/kg and > 5 x 10^6 CD34+ cells/kg (when achievable). For patients with multiple myeloma who may undergo tandem autologous SCT, > 8 x 10^6 CD34+ cells/kg will be collected (when achievable).
III. To assess the impact of bendamustine on B and T-lymphocyte populations in the peripheral blood (CD20+ cells, NK cells, CD4+25+ foxP3- regulatory cells, and CD8 cells)
OUTLINE:
Patients receive bendamustine hydrochloride IV over 60 minutes on days 1 and 2, oral dexamethasone on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until peripheral blood stem cell collection is complete.
Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.
After completion of study treatment, patients are followed for up to 5 years.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Intervention
bendamustine hydrochloride, dexamethasone, filgrastim, leukapheresis
Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle
Washington
United States
19024-1024
Status
Not yet recruiting
Source
Fred Hutchinson Cancer Research Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01110135
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:14:12-0400
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Medical and Biotech [MESH] Definitions
Bendamustine Hydrochloride
A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.
Nasal Lavage Fluid
Fluid obtained by irrigation or washout of the nasal cavity and NASAL MUCOSA. The resulting fluid is used in cytologic and immunologic assays of the nasal mucosa such as with the NASAL PROVOCATION TEST in the diagnosis of nasal hypersensitivity.
Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination
A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.
Metaplasia
A condition in which there is a change of one adult cell type to another similar adult cell type.
Nasal Cavity
The proximal portion of the respiratory passages on either side of the NASAL SEPTUM. Nasal cavities, extending from the nares to the NASOPHARYNX, are lined with ciliated NASAL MUCOSA.
