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Trial record 5 of 179 for:    LENALIDOMIDE AND Leukemia

Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

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ClinicalTrials.gov Identifier: NCT01123356
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
GlaxoSmithKline
Celgene Corporation
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Ofatumumab
Drug: Lenalidomide
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oratumumab and Lenalidomide
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Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles
Period Title: Overall Study
Started 21
Completed 14
Not Completed 7
Reason Not Completed
Adverse Event             2
Lack of Efficacy             4
Withdrawal by Subject             1
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  52.4%
>=65 years
10
  47.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
4
  19.0%
Male
17
  81.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
4
  19.0%
Not Hispanic or Latino
17
  81.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 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
4
  19.0%
White
17
  81.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description

Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).

Overall response rate was defined as those who experienced a response of CR, CRi or PR.

Time Frame 30 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description:

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53
(32 to 73)
2.Secondary Outcome
Title Frequency of Adverse and Severe Adverse Events
Hide Description Frequency of adverse and severe adverse events
Time Frame 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description:

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)

-Treatment to be administered for up to 6 cycles

Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
Number of SAEs 4
Neutropenia 19
grade 3/4 neutropenia 10
thrombocytopenia 15
grade 3/4 thrombocytopenia 4
tumor flare reaction 9
grade 3 tumor flare reaction 1
3.Secondary Outcome
Title Biomarkers Changes During Treatment.
Hide Description Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.
Time Frame 30 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description:

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)

-Treatment to be administered for up to 6 cycles

Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency of Adverse Events
Hide Description Number of adverse events occuring in greater than 20% of subjects
Time Frame 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description:

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)

-Treatment to be administered for up to 6 cycles

Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: events
15
5.Secondary Outcome
Title Dose Reductions Due to Adverse Events.
Hide Description Number of dose reductions due to toxicity.
Time Frame 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description:

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles

Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)

-Treatment to be administered for up to 6 cycles

Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: dose reductions
17
Time Frame [Not Specified]
Adverse Event Reporting Description All subjects enrolled on study were evaluated for toxicity.
 
Arm/Group Title Oratumumab and Lenalidomide
Hide Arm/Group Description

Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles
All-Cause Mortality
Oratumumab and Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oratumumab and Lenalidomide
Affected / at Risk (%)
Total   4/21 (19.05%) 
Blood and lymphatic system disorders   
Febrile Neutropenia  1  1/21 (4.76%) 
Investigations   
ALT Increase  1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Edema  1  1/21 (4.76%) 
Vascular disorders   
Thromboembolic Event  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oratumumab and Lenalidomide
Affected / at Risk (%)
Total   21/21 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  14/21 (66.67%) 
Cardiac disorders   
Tachycardia  1  7/21 (33.33%) 
Bradycardia  1  2/21 (9.52%) 
irregular heartbeat  1  1/21 (4.76%) 
sinus tachycardia  1  1/21 (4.76%) 
Ear and labyrinth disorders   
Meniere's disease  1  1/21 (4.76%) 
Eye disorders   
dry eye  1  1/21 (4.76%) 
itchy eye  1  1/21 (4.76%) 
watering eyes  1  1/21 (4.76%) 
Gastrointestinal disorders   
nausea  1  4/21 (19.05%) 
constipation  1  3/21 (14.29%) 
Abdominal discomfort  1  3/21 (14.29%) 
diarrhea  1  3/21 (14.29%) 
abdominal pain  1  2/21 (9.52%) 
vomiting  1  1/21 (4.76%) 
espophagitis  1  1/21 (4.76%) 
heartburn  1  1/21 (4.76%) 
General disorders   
fatigue  1  11/21 (52.38%) 
Tumor flare reaction  1  9/21 (42.86%) 
Infusion related reaction  1  7/21 (33.33%) 
Night Sweats  1  5/21 (23.81%) 
fever  1  4/21 (19.05%) 
pallor  1  3/21 (14.29%) 
chills  1  2/21 (9.52%) 
non-cardiac chest pain  1  1/21 (4.76%) 
edema face  1  1/21 (4.76%) 
Edema limbs  1  2/21 (9.52%) 
sweating  1  1/21 (4.76%) 
swollen feeling  1  1/21 (4.76%) 
Immune system disorders   
lymph node pain  1  4/21 (19.05%) 
Infections and infestations   
lymphadenopathy  1  1/21 (4.76%) 
pneumonia  1  3/21 (14.29%) 
cellulitis  1  1/21 (4.76%) 
Injury, poisoning and procedural complications   
bruising  1  1/21 (4.76%) 
Investigations   
Neutrophil count decreased  1  19/21 (90.48%) 
Platelet count decreased  1  15/21 (71.43%) 
Aspartate aminotransferase increased  1  7/21 (33.33%) 
creatinine increased  1  9/21 (42.86%) 
lactic dehydrogenase increased  1  6/21 (28.57%) 
Alanine amniotransferase increased  1  3/21 (14.29%) 
Blood bilirubin increased  1  3/21 (14.29%) 
hyperphosphatemia  1  4/21 (19.05%) 
hypermagnesemia  1  3/21 (14.29%) 
alkaline phosphatase increased  1  5/21 (23.81%) 
CO2 content decreased  1  3/21 (14.29%) 
uric acid decreased  1  1/21 (4.76%) 
hypogammaglobulinemia  1  1/21 (4.76%) 
white blood cell decreased  1  1/21 (4.76%) 
weight loss  1  1/21 (4.76%) 
chloride decreased  1  1/21 (4.76%) 
blood protein decreased  1  1/21 (4.76%) 
Metabolism and nutrition disorders   
hypernatremia  1  8/21 (38.10%) 
hyperglycemia  1  7/21 (33.33%) 
hypoalbuminemia  1  7/21 (33.33%) 
hypocalcemia  1  5/21 (23.81%) 
Hyperkalemia  1  4/21 (19.05%) 
hypophosphatemia  1  3/21 (14.29%) 
hyperuricemia  1  5/21 (23.81%) 
hypokalemia  1  2/21 (9.52%) 
anorexia  1  3/21 (14.29%) 
hypomagnesemia  1  2/21 (9.52%) 
chloride increased  1  3/21 (14.29%) 
dehydration  1  1/21 (4.76%) 
hypercalcemia  1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
leg cramps  1  4/21 (19.05%) 
weakness  1  3/21 (14.29%) 
back pain  1  3/21 (14.29%) 
pain in extremity  1  3/21 (14.29%) 
neck pain  1  1/21 (4.76%) 
muscle cramping  1  2/21 (9.52%) 
Nervous system disorders   
dizziness  1  7/21 (33.33%) 
dysgeusia  1  1/21 (4.76%) 
paresthesia  1  1/21 (4.76%) 
Psychiatric disorders   
insomnia  1  4/21 (19.05%) 
agitation  1  1/21 (4.76%) 
mood swings  1  1/21 (4.76%) 
Renal and urinary disorders   
acute renal failure  1  2/21 (9.52%) 
renal insufficiency  1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  8/21 (38.10%) 
cough  1  6/21 (28.57%) 
allergic rhinitis  1  2/21 (9.52%) 
bronchitis  1  2/21 (9.52%) 
wheezing  1  2/21 (9.52%) 
upper respiratory infection  1  2/21 (9.52%) 
pleuritic pain  1  1/21 (4.76%) 
hypoxia  1  1/21 (4.76%) 
pleural effusion  1  1/21 (4.76%) 
sore throat  1  2/21 (9.52%) 
nasal congestion  1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
actinic keratosis  1  1/21 (4.76%) 
skin hyperpigmentation  1  1/21 (4.76%) 
pruritis  1  1/21 (4.76%) 
alopecia  1  1/21 (4.76%) 
dry skin  1  1/21 (4.76%) 
sunburn  1  1/21 (4.76%) 
rash maculopapular  1  1/21 (4.76%) 
rash (NOS)  1  1/21 (4.76%) 
Vascular disorders   
hypotension  1  3/21 (14.29%) 
hypertension  1  4/21 (19.05%) 
hot flashes  1  2/21 (9.52%) 
flushing  1  1/21 (4.76%) 
pulmonari emboli  1  1/21 (4.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Clinical Trials Network Manager
Organization: Medical University of South Carolina
Phone: 843-792-1753
EMail: adraleta@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01123356     History of Changes
Other Study ID Numbers: 101376 OFT113297
First Submitted: May 4, 2010
First Posted: May 14, 2010
Results First Submitted: April 21, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015