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Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705250
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : January 19, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin's Disease
Lymphoma
Intervention Drug: bendamustine hcl
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion.
Period Title: Overall Study
Started 36
Completed 34
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Patient died in car accident             1
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
34
(21 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
23
  63.9%
Male
13
  36.1%
1.Primary Outcome
Title Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.
Hide Description The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of evaluable participants
56
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   5/36 (13.89%) 
Blood and lymphatic system disorders   
Self-limited Gross Hematuria  1  1/36 (2.78%) 
Gastrointestinal disorders   
Vomiting  1  1/36 (2.78%) 
General disorders   
Febrile neutropenia  1  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/36 (2.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   36/36 (100.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  18/36 (50.00%) 
Anemia  1  5/36 (13.89%) 
Neutropenia  1  3/36 (8.33%) 
Gastrointestinal disorders   
Nausea  1  18/36 (50.00%) 
Vomiting  1  8/36 (22.22%) 
Constipation  1  3/36 (8.33%) 
Mucositis  1  2/36 (5.56%) 
General disorders   
Fatigue  1  30/36 (83.33%) 
Fever  1  4/36 (11.11%) 
Pneumonia  1  4/36 (11.11%) 
Febrile Neutropenia  1  2/36 (5.56%) 
Hematuria  1  2/36 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/36 (22.22%) 
Dyspnea  1  7/36 (19.44%) 
Respiratory Infection  1  3/36 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
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: Craig Moskowitz, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: (212) 639-7992
EMail: moskowic@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00705250     History of Changes
Other Study ID Numbers: 08-041
First Submitted: June 24, 2008
First Posted: June 26, 2008
Results First Submitted: November 21, 2016
Results First Posted: January 19, 2017
Last Update Posted: March 3, 2017