Bendamustine Hydrochloride, Etoposide, Dexamethasone, and Filgrastim For Peripheral Blood Stem Cell Mobilization in Treating Patients With Refractory or Recurrent Lymphoma or Multiple Myeloma
NCT ID: NCT01110135
Last Updated: 2017-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2010-08-31
Brief Summary
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Detailed Description
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I. To estimate the frequency of bendamustine (bendamustine hydrochloride) combined with GCSF (filgrastim) and dexamethasone to successfully mobilize peripheral blood stem cells (PBSCs) (as determined by collecting a minimum of 2 x 10\^6 cluster of differentiation (CD)34+/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 ideally \>= 5 x 10\^6 CD34+ cells/kg (when achievable).
III. To assess the impact of bendamustine on B and T-lymphocyte populations in the peripheral blood (CD20+ cells, natural killer \[NK\] cells, CD4+25+ foxP3- regulatory cells, and CD8 cells).
OUTLINE:
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone orally (PO) on days 1-4, and filgrastim subcutaneously (SC) beginning on day 5 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy and colony-stimulating factor)
Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 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.
.
bendamustine hydrochloride
Given IV
dexamethasone
Given PO
filgrastim
Given SC
leukapheresis
Given IV
laboratory biomarker analysis
Correlative studies
flow cytometry
Correlative studies
etoposide
Given IV
Interventions
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bendamustine hydrochloride
Given IV
dexamethasone
Given PO
filgrastim
Given SC
leukapheresis
Given IV
laboratory biomarker analysis
Correlative studies
flow cytometry
Correlative studies
etoposide
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* World Health Organization (WHO) classification of patients' malignancies must be provided
* Patients with lymphoid malignancies must have a computed tomography (CT) of chest, abdomen, and pelvis within six weeks of enrollment; patients with evidence of lymphadenopathy in the neck must have a CT of neck
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelets \>= 100,000/mm\^3 (without transfusion or growth factor support)
* Creatinine clearance (CrCl) greater than 50/ml per minute (all tests must be performed within 28 days prior to registration)
* Total bilirubin \< 1.5 times upper limit of normal
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal
* All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
* Adequate venous access plan in place for apheresis procedure
* Three or fewer prior myelotoxic treatment regimens (specific regimens include ifosfamide, carboplatin and etoposide \[ICE\]; cisplatin, cytarabine, and dexamethasone \[DHAP\]; methotrexate \[MTX\]/high-dose cytarabine \[HiDAC\]; cyclophosphamide, vincristine, doxorubicin, and dexamethasone \[hyperCVAD\]; bortezomib, thalidomide, dexamethasone and 4-day continuous infusions of cisplatin, doxorubicin, cyclophosphamide, and etoposide \[VTD-PACE\])
Exclusion Criteria
* Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
* Greater than six prior cycles of lenalidomide therapy
* Patients who have previously demonstrated resistance to bendamustine therapy (i.e. no response or progression w/in 6 months)
* Fludarabine or other nucleoside analog (except gemcitabine or cytarabine) therapy within 24 months of registration; patients with limited exposure to fludarabine/other nucleoside analog therapy within 24 months may be considered eligible with review and approval by the PI or Co-PI prior to study entry
* Symptomatic cardiopulmonary disease
* Prior autologous or allogeneic transplantation
* Prior radioimmunotherapy within 12 weeks of registration
* Prior failed (\< 5 x 10\^6 CD34/kg) PBSC collection due to inability to mobilize stem cells
* Prior pelvic or spinal irradiation
* Previous systemic chemotherapy/immunotherapy within 3 weeks before study entry
* Concurrent use of other anti-cancer agents or experimental treatments
* Known allergy or intolerance to bendamustine, mannitol, GCSF or dexamethasone
* More than 3 cycles of myelotoxic salvage chemotherapy within the past 4 months (specific regimens include ICE, DHAP, MTX/HiDAC, hyperCVAD, VTD-PACE)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Ajay Gopal
Principal Investigator
Principal Investigators
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Ajay Gopal
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-00509
Identifier Type: REGISTRY
Identifier Source: secondary_id
7176
Identifier Type: -
Identifier Source: org_study_id
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