Trial Outcomes & Findings for Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (NCT NCT00439231)
NCT ID: NCT00439231
Last Updated: 2014-01-13
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
24 weeks of lenalidomide therapy
Results posted on
2014-01-13
Participant Flow
Participant milestones
| Measure |
CLL Subjects Response to Lenalidomide (Revlimid)
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.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
CLL Subjects Response to Lenalidomide (Revlimid)
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.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
28
|
Baseline Characteristics
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
CLL Subjects Response to Lenalidomide (Revlimid)
n=33 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks of lenalidomide therapyTo 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
Outcome measures
| Measure |
CLL Subject Response Rate After Lenalidomide Therapy
n=33 Participants
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.
|
|---|---|
|
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
Partial response
|
5 participants
|
|
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
No response
|
28 participants
|
|
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
Complete response
|
0 participants
|
Adverse Events
CLL Subjects Treated With Lenalidomide (Revlimid)
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLL Subjects Treated With Lenalidomide (Revlimid)
n=33 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
DVT
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Tumor flare syndrome
|
21.2%
7/33
|
Other adverse events
| Measure |
CLL Subjects Treated With Lenalidomide (Revlimid)
n=33 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
ankle edema
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
bruising inner arm
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
decrease in hemoglobin
|
24.2%
8/33
|
|
Blood and lymphatic system disorders
decrease in neutrophils
|
57.6%
19/33
|
|
Blood and lymphatic system disorders
decrease in platelets
|
57.6%
19/33
|
|
Blood and lymphatic system disorders
DVT leg
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
elbow bruising
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
flu like symptoms
|
9.1%
3/33
|
|
Blood and lymphatic system disorders
hematoma
|
6.1%
2/33
|
|
Blood and lymphatic system disorders
hypophosphatemia
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
increase ALT
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
lymph node swelling
|
9.1%
3/33
|
|
Blood and lymphatic system disorders
lymphedema
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
swollen lymph node
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Tumor flare syndrome
|
39.4%
13/33
|
|
Cardiac disorders
hypotension
|
6.1%
2/33
|
|
Ear and labyrinth disorders
decreased hearing
|
3.0%
1/33
|
|
Ear and labyrinth disorders
ear pressure
|
3.0%
1/33
|
|
Ear and labyrinth disorders
middle ear pain
|
3.0%
1/33
|
|
Eye disorders
blurred vision
|
3.0%
1/33
|
|
Eye disorders
dry eye
|
3.0%
1/33
|
|
Eye disorders
edema ocular
|
3.0%
1/33
|
|
Eye disorders
uvietus
|
3.0%
1/33
|
|
Gastrointestinal disorders
abdominal bloating
|
9.1%
3/33
|
|
Gastrointestinal disorders
abdominal cramps
|
9.1%
3/33
|
|
Gastrointestinal disorders
abdominal distention
|
6.1%
2/33
|
|
Gastrointestinal disorders
abdominal pain
|
24.2%
8/33
|
|
Gastrointestinal disorders
change in taste
|
9.1%
3/33
|
|
Gastrointestinal disorders
constipation
|
24.2%
8/33
|
|
Gastrointestinal disorders
decrease in creatinine
|
3.0%
1/33
|
|
Gastrointestinal disorders
diarrhea
|
27.3%
9/33
|
|
Gastrointestinal disorders
dry mouth
|
3.0%
1/33
|
|
Gastrointestinal disorders
heartburn
|
3.0%
1/33
|
|
Gastrointestinal disorders
increase ALT
|
6.1%
2/33
|
|
Gastrointestinal disorders
increase AST
|
6.1%
2/33
|
|
Gastrointestinal disorders
nausea
|
15.2%
5/33
|
|
Gastrointestinal disorders
organomegaly
|
3.0%
1/33
|
|
Gastrointestinal disorders
stomach pain
|
3.0%
1/33
|
|
Gastrointestinal disorders
urinary tract infection
|
3.0%
1/33
|
|
Gastrointestinal disorders
vomiting
|
9.1%
3/33
|
|
General disorders
ankle swelling
|
3.0%
1/33
|
|
General disorders
chills
|
12.1%
4/33
|
|
General disorders
cold sore
|
3.0%
1/33
|
|
General disorders
cough
|
3.0%
1/33
|
|
General disorders
fatigue
|
57.6%
19/33
|
|
General disorders
fever
|
15.2%
5/33
|
|
General disorders
insomnia
|
3.0%
1/33
|
|
General disorders
lower extremity edema
|
3.0%
1/33
|
|
General disorders
mouth lesion
|
3.0%
1/33
|
|
General disorders
mouth/lip sore
|
3.0%
1/33
|
|
General disorders
pedal edema
|
3.0%
1/33
|
|
General disorders
sweating
|
18.2%
6/33
|
|
General disorders
weight loss
|
27.3%
9/33
|
|
Infections and infestations
CMV infection
|
3.0%
1/33
|
|
Infections and infestations
Gastrointestinal infection
|
3.0%
1/33
|
|
Infections and infestations
gum infection
|
3.0%
1/33
|
|
Infections and infestations
oral cavity infeciton
|
3.0%
1/33
|
|
Infections and infestations
oral ulcers
|
3.0%
1/33
|
|
Infections and infestations
shingles
|
3.0%
1/33
|
|
Infections and infestations
tooth abscess
|
3.0%
1/33
|
|
Infections and infestations
upper respiratory infection
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
arm pain
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
back pain
|
15.2%
5/33
|
|
Musculoskeletal and connective tissue disorders
bruising arms & back
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
elbow pain
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
feet pain
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
foot cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
foot/ankle pain
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
general body aches
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
generalize bruising
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
hand cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
leg cramp
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
leg cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
lower extremity cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
lower extremity leg cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
lower extremity pain
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
lower extremity rash
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
muscle cramp
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
6.1%
2/33
|
|
Musculoskeletal and connective tissue disorders
ocular infection
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
petechiae legs
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
pleuritic back pain
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
scalp rash
|
3.0%
1/33
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
9.1%
3/33
|
|
Musculoskeletal and connective tissue disorders
skin rash
|
3.0%
1/33
|
|
Nervous system disorders
agitation
|
3.0%
1/33
|
|
Nervous system disorders
hallucinations
|
3.0%
1/33
|
|
Nervous system disorders
head/ arm nueropathy
|
3.0%
1/33
|
|
Nervous system disorders
headache
|
18.2%
6/33
|
|
Nervous system disorders
insomnia
|
6.1%
2/33
|
|
Nervous system disorders
syncope
|
36.4%
12/33
|
|
Psychiatric disorders
depressed
|
3.0%
1/33
|
|
Reproductive system and breast disorders
upper respiratory infection
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.1%
3/33
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
30.3%
10/33
|
|
Respiratory, thoracic and mediastinal disorders
mouth lesion
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary infiltrate
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
rales
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
throat pain
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
48.5%
16/33
|
|
Skin and subcutaneous tissue disorders
facial rash
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
hand rash
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
head rash
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
knee rash
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
pruritis
|
15.2%
5/33
|
|
Skin and subcutaneous tissue disorders
rash axilla
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
rash chest
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
rash leg
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
rash scalp
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
rash torso
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
rash waistband
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
scalp rash
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
skin rash
|
42.4%
14/33
|
|
Skin and subcutaneous tissue disorders
skin rash lip
|
3.0%
1/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place