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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, University of Washington
ClinicalTrials.gov Identifier:
NCT01110135
First received: April 20, 2010
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: April 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Treatment (Chemotherapy and Colony-stimulating Factor)
STARTED   43 
COMPLETED   34 
NOT COMPLETED   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   Treatment (Chemotherapy and Colony-stimulating Factor) 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Median (Full Range)
 61 
 (46 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  29.4% 
Male      24  70.6% 


  Outcome Measures

1.  Primary:   Successful Mobilization and Collection of PBSCs   [ Time Frame: Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
phone: 206-288-2037
e-mail: akgopal@fhcrc.org



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) )
Study First Received: April 20, 2010
Results First Received: April 14, 2017
Last Updated: April 14, 2017