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Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT01002755
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Fatigue
Fever
Hypogammaglobulinemia
Lymphadenopathy
Lymphocytosis
Night Sweats
Paraproteinemia
Small Lymphocytic Lymphoma
Thrombocytopenia
Interventions Drug: Lenalidomide
Biological: Ofatumumab
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

Period Title: Overall Study
Started 36
Completed 36
Not Completed 0
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

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
64
(34 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
9
  25.0%
Male
27
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   8.3%
White
32
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title Overall Response Rate
Hide Description A Simon’s two-stage minmax design will be used. Includes complete remission (CR) and partial remission (PR). Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow. Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not evaluable for response.
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description:

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
24
  70.6%
2.Secondary Outcome
Title Number of Participants With Tolerance of the Medication Combination
Hide Description Incidence of grade 3 and 4 non-hematological toxicity in more than 50 percent of the participants. Will be monitored based on the Bayesian model (beta-binomial).
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description:

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Progression Free Survival
Hide Description The time from the start of therapy to death, disease progression, or the initiation of the next therapy. Disease progression is the loss of response or transformation to a more aggressive histology.
Time Frame Up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description:

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
16
(2 to 26)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide, Ofatumumab)
Hide Arm/Group Description

Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Given PO

Ofatumumab: Given IV

All-Cause Mortality
Treatment (Lenalidomide, Ofatumumab)
Affected / at Risk (%)
Total   0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide, Ofatumumab)
Affected / at Risk (%) # Events
Total   13/36 (36.11%)    
Blood and lymphatic system disorders   
Thrombosis  1  2/36 (5.56%)  2
Cardiac disorders   
Atrial Fibrillation  1  1/36 (2.78%)  2
General disorders   
Fatigue  1  1/36 (2.78%)  1
Fever  1  3/36 (8.33%)  4
Weakness  1  1/36 (2.78%)  1
Infections and infestations   
Infection  1  3/36 (8.33%)  3
Meninogencephalitis  1  1/36 (2.78%)  1
Neutropenic Fever  1  1/36 (2.78%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/36 (5.56%)  4
Pulmonary Embolism  1  1/36 (2.78%)  1
Surgical and medical procedures   
Appendectomy  1  1/36 (2.78%)  1
Hernia repair  1  1/36 (2.78%)  1
1
Term from vocabulary, CTCAE (3.0)
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%
Treatment (Lenalidomide, Ofatumumab)
Affected / at Risk (%) # Events
Total   33/36 (91.67%)    
Blood and lymphatic system disorders   
Anemia  1  10/36 (27.78%)  10
Edema Limb  1  2/36 (5.56%)  2
Neutropenia  1  23/36 (63.89%)  23
Thrombocytopenia  1  12/36 (33.33%)  12
Eye disorders   
Dry eye  1  2/36 (5.56%)  2
Gastrointestinal disorders   
Constipation  1  12/36 (33.33%)  12
Diarrhea  1  15/36 (41.67%)  15
Distention/Bloating  1  2/36 (5.56%)  2
Nausea  1  9/36 (25.00%)  9
Vomiting  1  3/36 (8.33%)  3
General disorders   
Cough  1  8/36 (22.22%)  8
Fatigue  1  16/36 (44.44%)  16
Fever  1  14/36 (38.89%)  14
Pain  1  16/36 (44.44%)  16
Sweating  1  2/36 (5.56%)  2
Immune system disorders   
Tumor Flare  1  7/36 (19.44%)  7
Infections and infestations   
Infection  1  20/36 (55.56%)  20
Investigations   
Allergic Drug Reaction  1  8/36 (22.22%)  11
Metabolism and nutrition disorders   
Hyperglycemia  1  2/36 (5.56%)  2
Hypomagnesemia  1  2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1  2/36 (5.56%)  2
Nervous system disorders   
Insomnia  1  2/36 (5.56%)  2
Neurology other  1  5/36 (13.89%)  5
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  5/36 (13.89%)  5
Pleural Effusion  1  2/36 (5.56%)  2
Pulmonary Other  1  3/36 (8.33%)  3
Skin and subcutaneous tissue disorders   
Acne  1  3/36 (8.33%)  3
Dermatology/Skin  1  2/36 (5.56%)  2
Dry Skin  1  2/36 (5.56%)  2
Pruritis  1  6/36 (16.67%)  6
Rash/desquamation  1  2/36 (5.56%)  2
1
Term from vocabulary, CTCAE (3.0)
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: Ferrajoli,Alessandra M.D.
Organization: The University of Texas M D Anderson Cancer Center
Phone: 713-792-2063
EMail: aferrajo@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01002755     History of Changes
Other Study ID Numbers: 2009-0283
NCI-2018-01829 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2009-0283 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: October 26, 2009
First Posted: October 27, 2009
Results First Submitted: January 17, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019