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Trial record 29 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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ClinicalTrials.gov Identifier: NCT00439231
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Georg Aue, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Intervention Drug: Lenalidomide
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CLL Subjects Response to Lenalidomide (Revlimid)
Hide Arm/Group Description To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
Period Title: Overall Study
Started 33
Completed 5 [1]
Not Completed 28
Reason Not Completed
Lack of Efficacy             28
[1]
5 subjects had a partial response, 0 complete response, 28 completed off study,
Arm/Group Title CLL Subjects Response to Lenalidomide (Revlimid)
Hide Arm/Group Description To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  57.6%
>=65 years
14
  42.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
7
  21.2%
Male
26
  78.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
29
  87.9%
Unknown or Not Reported
4
  12.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 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
  12.1%
White
26
  78.8%
More than one race
0
   0.0%
Unknown or Not Reported
3
   9.1%
1.Primary Outcome
Title To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
Hide Description To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen
Time Frame 24 weeks of lenalidomide therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CLL Subject Response Rate After Lenalidomide Therapy
Hide Arm/Group Description:
To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 5
No response 28
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CLL Subjects Treated With Lenalidomide (Revlimid)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
CLL Subjects Treated With Lenalidomide (Revlimid)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CLL Subjects Treated With Lenalidomide (Revlimid)
Affected / at Risk (%)
Total   8/33 (24.24%) 
Blood and lymphatic system disorders   
DVT  1/33 (3.03%) 
Tumor flare syndrome  7/33 (21.21%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CLL Subjects Treated With Lenalidomide (Revlimid)
Affected / at Risk (%)
Total   32/33 (96.97%) 
Blood and lymphatic system disorders   
ankle edema  1/33 (3.03%) 
bruising inner arm  1/33 (3.03%) 
decrease in hemoglobin  8/33 (24.24%) 
decrease in neutrophils  19/33 (57.58%) 
decrease in platelets  19/33 (57.58%) 
DVT leg  1/33 (3.03%) 
elbow bruising  1/33 (3.03%) 
flu like symptoms  3/33 (9.09%) 
hematoma  2/33 (6.06%) 
hypophosphatemia  1/33 (3.03%) 
increase ALT  1/33 (3.03%) 
lymph node swelling  3/33 (9.09%) 
lymphedema  1/33 (3.03%) 
swollen lymph node  1/33 (3.03%) 
Tumor flare syndrome  13/33 (39.39%) 
Cardiac disorders   
hypotension  2/33 (6.06%) 
Ear and labyrinth disorders   
decreased hearing  1/33 (3.03%) 
ear pressure  1/33 (3.03%) 
middle ear pain  1/33 (3.03%) 
Eye disorders   
blurred vision  1/33 (3.03%) 
dry eye  1/33 (3.03%) 
edema ocular  1/33 (3.03%) 
uvietus  1/33 (3.03%) 
Gastrointestinal disorders   
abdominal bloating  3/33 (9.09%) 
abdominal cramps  3/33 (9.09%) 
abdominal distention  2/33 (6.06%) 
abdominal pain  8/33 (24.24%) 
change in taste  3/33 (9.09%) 
constipation  8/33 (24.24%) 
decrease in creatinine  1/33 (3.03%) 
diarrhea  9/33 (27.27%) 
dry mouth  1/33 (3.03%) 
heartburn  1/33 (3.03%) 
increase ALT  2/33 (6.06%) 
increase AST  2/33 (6.06%) 
nausea  5/33 (15.15%) 
organomegaly  1/33 (3.03%) 
stomach pain  1/33 (3.03%) 
urinary tract infection  1/33 (3.03%) 
vomiting  3/33 (9.09%) 
General disorders   
ankle swelling  1/33 (3.03%) 
chills  4/33 (12.12%) 
cold sore  1/33 (3.03%) 
cough  1/33 (3.03%) 
fatigue  19/33 (57.58%) 
fever  5/33 (15.15%) 
insomnia  1/33 (3.03%) 
lower extremity edema  1/33 (3.03%) 
mouth lesion  1/33 (3.03%) 
mouth/lip sore  1/33 (3.03%) 
pedal edema  1/33 (3.03%) 
sweating  6/33 (18.18%) 
weight loss  9/33 (27.27%) 
Infections and infestations   
CMV infection  1/33 (3.03%) 
Gastrointestinal infection  1/33 (3.03%) 
gum infection  1/33 (3.03%) 
oral cavity infeciton  1/33 (3.03%) 
oral ulcers  1/33 (3.03%) 
shingles  1/33 (3.03%) 
tooth abscess  1/33 (3.03%) 
upper respiratory infection  1/33 (3.03%) 
Musculoskeletal and connective tissue disorders   
arm pain  2/33 (6.06%) 
back pain  5/33 (15.15%) 
bruising arms &amp; back  1/33 (3.03%) 
chest pain  1/33 (3.03%) 
elbow pain  2/33 (6.06%) 
feet pain  1/33 (3.03%) 
foot cramps  1/33 (3.03%) 
foot/ankle pain  1/33 (3.03%) 
general body aches  1/33 (3.03%) 
generalize bruising  1/33 (3.03%) 
hand cramps  1/33 (3.03%) 
joint pain  1/33 (3.03%) 
leg cramp  1/33 (3.03%) 
leg cramps  1/33 (3.03%) 
leg pain  2/33 (6.06%) 
lower extremity cramps  1/33 (3.03%) 
lower extremity leg cramps  1/33 (3.03%) 
lower extremity pain  3/33 (9.09%) 
lower extremity rash  1/33 (3.03%) 
muscle cramp  1/33 (3.03%) 
muscle cramps  1/33 (3.03%) 
Musculoskeletal pain  2/33 (6.06%) 
neck pain  2/33 (6.06%) 
ocular infection  1/33 (3.03%) 
petechiae legs  1/33 (3.03%) 
pleuritic back pain  1/33 (3.03%) 
scalp rash  1/33 (3.03%) 
shoulder pain  3/33 (9.09%) 
skin rash  1/33 (3.03%) 
Nervous system disorders   
agitation  1/33 (3.03%) 
hallucinations  1/33 (3.03%) 
head/ arm nueropathy  1/33 (3.03%) 
headache  6/33 (18.18%) 
insomnia  2/33 (6.06%) 
syncope  12/33 (36.36%) 
Psychiatric disorders   
depressed  1/33 (3.03%) 
Reproductive system and breast disorders   
upper respiratory infection  1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders   
bronchitis  1/33 (3.03%) 
cough  3/33 (9.09%) 
dyspnea  10/33 (30.30%) 
mouth lesion  1/33 (3.03%) 
pulmonary infiltrate  1/33 (3.03%) 
rales  1/33 (3.03%) 
sinus infection  1/33 (3.03%) 
sore throat  2/33 (6.06%) 
throat pain  1/33 (3.03%) 
upper respiratory infection  16/33 (48.48%) 
Skin and subcutaneous tissue disorders   
facial rash  1/33 (3.03%) 
hand rash  1/33 (3.03%) 
head rash  1/33 (3.03%) 
knee rash  1/33 (3.03%) 
pruritis  5/33 (15.15%) 
rash axilla  1/33 (3.03%) 
rash chest  1/33 (3.03%) 
rash leg  1/33 (3.03%) 
rash scalp  2/33 (6.06%) 
rash torso  1/33 (3.03%) 
rash waistband  1/33 (3.03%) 
scalp rash  2/33 (6.06%) 
skin rash  14/33 (42.42%) 
skin rash lip  1/33 (3.03%) 
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: Georg Aue
Organization: NHLBI/NIH
Phone: 301.451.7141
EMail: AueG@nhlbi.nih.gov
Layout table for additonal information
Responsible Party: Georg Aue, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00439231     History of Changes
Obsolete Identifiers: NCT00465127
Other Study ID Numbers: 070104
07-H-0104 ( Other Identifier: NIH NHLBI )
First Submitted: February 22, 2007
First Posted: February 23, 2007
Results First Submitted: September 19, 2011
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014