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Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT01010568
Recruitment Status : Terminated (Unable to accrue patients due to change in standard CLL therapy)
First Posted : November 10, 2009
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
GlaxoSmithKline
Cephalon
Information provided by (Responsible Party):
Georgetown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention Drug: Ofatumumab and Bendamustine
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
Period Title: Overall Study
Started 10
Completed 5
Not Completed 5
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description

Ofatumumab and Bendamustine

Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  60.0%
>=65 years
4
  40.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
63
(52 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Overall Response Rate
Hide Description 40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:

Ofatumumab and Bendamustine

Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Complete Response Rate
Hide Description NCI IWG response criteria
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:
Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
2
3.Secondary Outcome
Title Median PFS
Hide Description Kaplan Meyer PFS
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description:

Ofatumumab and Bendamustine

Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: months
8.1
(3.2 to 22.6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ofatumumab and Bendamustine
Hide Arm/Group Description

Ofatumumab and Bendamustine

Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

All-Cause Mortality
Ofatumumab and Bendamustine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ofatumumab and Bendamustine
Affected / at Risk (%) # Events
Total   3/10 (30.00%)    
Blood and lymphatic system disorders   
Neutropenia * 1  2/10 (20.00%)  2
General disorders   
Fatigue * 1  3/10 (30.00%)  3
Infections and infestations   
Infection * 1  2/10 (20.00%)  2
Injury, poisoning and procedural complications   
Infusion related reaction * 1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle Weakness * 1  2/10 (20.00%)  2
Nervous system disorders   
Ataxia * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ofatumumab and Bendamustine
Affected / at Risk (%) # Events
Total   9/10 (90.00%)    
Blood and lymphatic system disorders   
Neutropenia * 1  8/10 (80.00%)  8
Anemia * 1  8/10 (80.00%)  8
Thrombocytopenia * 1  1/10 (10.00%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/10 (20.00%)  2
Nausea * 1  4/10 (40.00%)  4
General disorders   
fatigue * 1  6/10 (60.00%)  6
Fever * 1  5/10 (50.00%)  5
Hepatobiliary disorders   
Hyperbilirubinemia * 1  3/10 (30.00%)  3
Infections and infestations   
Infection * 1  6/10 (60.00%)  6
Injury, poisoning and procedural complications   
Allergy/infusion reaction * 1  5/10 (50.00%)  5
Musculoskeletal and connective tissue disorders   
Muscle Weakness * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  2/10 (20.00%)  2
Pneumonitis * 1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  5/10 (50.00%)  5
Vascular disorders   
Phlebitis * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruce D. Cheson
Organization: Georgetown University Hospital
Phone: 202-444-1212
EMail: bdc4@georgetown.edu
Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01010568     History of Changes
Other Study ID Numbers: OB2009-315
First Submitted: October 19, 2009
First Posted: November 10, 2009
Results First Submitted: July 22, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015