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

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ClinicalTrials.gov Identifier: NCT01110135
Recruitment Status : Completed
First Posted : April 26, 2010
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Drug: bendamustine hydrochloride
Drug: dexamethasone
Biological: filgrastim
Procedure: leukapheresis
Other: laboratory biomarker analysis
Other: flow cytometry
Drug: etoposide
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy and Colony-stimulating Factor)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 43
Completed 34
Not Completed 9
Arm/Group Title Treatment (Chemotherapy and Colony-stimulating Factor)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
61
(46 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
10
  29.4%
Male
24
  70.6%
1.Primary Outcome
Title Successful Mobilization and Collection of PBSCs
Hide Description Count of participants with successful mobilization and collection of PBSCs. Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.
Time Frame Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy and Colony-stimulating Factor)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
34
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy and Colony-stimulating Factor)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Chemotherapy and Colony-stimulating Factor)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemotherapy and Colony-stimulating Factor)
Affected / at Risk (%)
Total   6/34 (17.65%) 
Blood and lymphatic system disorders   
Neutropenic fever  1/34 (2.94%) 
Cardiac disorders   
Atrial fibrillation  1/34 (2.94%) 
Infections and infestations   
Sepsis  1/34 (2.94%) 
Nervous system disorders   
Stroke  1/34 (2.94%) 
Renal and urinary disorders   
Renal insufficiency  1/34 (2.94%) 
Vascular disorders   
Hypotension  2/34 (5.88%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Chemotherapy and Colony-stimulating Factor)
Affected / at Risk (%)
Total   34/34 (100.00%) 
Blood and lymphatic system disorders   
Lymphopenia  34/34 (100.00%) 
Thrombocytopenia  31/34 (91.18%) 
Neutropenia  33/34 (97.06%) 
Leukopenia  26/34 (76.47%) 
Metabolism and nutrition disorders   
Hypophosphatemia  6/34 (17.65%) 
Hyperglycemia  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness  2/34 (5.88%) 
Vascular disorders   
Hypotension  2/34 (5.88%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
EMail: akgopal@fhcrc.org
Layout table for additonal information
Responsible Party: Ajay Gopal, University of Washington
ClinicalTrials.gov Identifier: NCT01110135     History of Changes
Other Study ID Numbers: 7176
NCI-2010-00509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 20, 2010
First Posted: April 26, 2010
Results First Submitted: April 14, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017