Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma

This study is currently recruiting participants.
Verified May 2012 by Fred Hutchinson Cancer Research Center

First Received on April 20, 2010.  
Last Updated on May 17, 2012  
History of Changes
This Clinical Trial Sponsored By: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01110135
 

Purpose for Clinical Trial

This phase II trial is studying how well giving bendamustine hydrochloride, etoposide, dexamethasone, and filgrastim together for peripheral stem cell mobilization works in treating patients with refractory or recurrent lymphoma or multiple myeloma. Giving chemotherapy, such as bendamustine hydrochloride, etoposide, 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 filgrastim, and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected and stored

Condition Study Intervention Clinical Trial Phase
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Multiple Myeloma
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Drug: bendamustine hydrochloride
Drug: dexamethasone
Biological: filgrastim
Procedure: leukapheresis
Other: laboratory biomarker analysis
Other: flow cytometry
Drug: etoposide
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED)

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone Sodium Phosphate
Bendamustine hydrochloride
Bendamustine
Etoposide
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures For Clinical Trial:

  • Successful mobilization and collection of PBSCs [ Time Frame: 6 weeks post PBSC collection ] [ Designated as safety issue: No ]
    Defined as collection of > 2 x 10^6 CD34/kg within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.

Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

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