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Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

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ClinicalTrials.gov Identifier: NCT00426855
Recruitment Status : Completed
First Posted : January 25, 2007
Results First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Kantonsspital Aarau
Information provided by (Responsible Party):
Peter Moosmann, Kantonsspital Aarau

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma, Non-Hodgkin
Interventions Drug: Bendamustine
Drug: Bortezomib
Enrollment 12
Recruitment Details Twelve consecutive patients of a medical clinic were included in the trial.
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description Bortezomib, Bendamustine, NHL, combination chemotherapy
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description Bortezomib, Bendamustin, combination chemotherapy in nhl
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  33.3%
>=65 years
8
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
10
  83.3%
Male
2
  16.7%
1.Primary Outcome
Title Optimal Bendamustine Dosage for Further Studies
Hide Description [Not Specified]
Time Frame Three weeks after treatment termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
NHL treated with combination chemotherapy of bendamustin and bortezomib
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mg/m^2
60
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description NHL Patients treated with combination of bendamustine and bortezomib
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%) # Events
Total   1/12 (8.33%)    
Blood and lymphatic system disorders   
Thrombocytopenia   1/12 (8.33%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1
Affected / at Risk (%) # Events
Total   12/12 (100.00%)    
Blood and lymphatic system disorders   
Anemia   1/12 (8.33%)  1
Leukopenia   5/12 (41.67%)  5
Neutropenia   2/12 (16.67%)  2
Cardiac disorders   
Dehydration   2/12 (16.67%)  2
Gastrointestinal disorders   
Diarrhea   10/12 (83.33%)  10
Nausea   8/12 (66.67%)  8
Vomiting   6/12 (50.00%)  6
Stomatitis   1/12 (8.33%)  1
Hemorrhage, gastrointestinal   1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness   1/12 (8.33%)  1
Nervous system disorders   
Neuropathy, motor   1/12 (8.33%)  1
Neuropathy, sensory   2/12 (16.67%)  2
Psychiatric disorders   
Fatigue   6/12 (50.00%)  6
Indicates events were collected by systematic assessment
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: Dr. Peter Moosmann
Organization: Kantonsspital Aarau
Phone: +41 62 838 60 51
EMail: peter.moosmann@ksa.ch
Layout table for additonal information
Responsible Party: Peter Moosmann, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT00426855     History of Changes
Other Study ID Numbers: ZOHT-01/07
First Submitted: January 24, 2007
First Posted: January 25, 2007
Results First Submitted: June 27, 2011
Results First Posted: April 3, 2015
Last Update Posted: April 3, 2015