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Trial record 38 of 178 for:    LENALIDOMIDE AND Leukemia

Phase II Trial of Revlimid® and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT01199575
Recruitment Status : Active, not recruiting
First Posted : September 13, 2010
Results First Posted : October 23, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Thomas Kipps, University of California, San Diego

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
CLL
Interventions Drug: Revlimid
Drug: Rituximab
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Revlimid + Rituximab
Hide Arm/Group Description

Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.

Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

Period Title: Overall Study
Started 30
Completed 25
Not Completed 5
Reason Not Completed
Withdrawal by Subject             5
Arm/Group Title Revlimid + Rituximab
Hide Arm/Group Description

Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.

Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  36.7%
>=65 years
19
  63.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
11
  36.7%
Male
19
  63.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 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
0
   0.0%
White
30
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description [Not Specified]
Time Frame nine months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid + Rituximab
Hide Arm/Group Description:

A: Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.

Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

Revlimid

Rituximab

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
2.Secondary Outcome
Title Adverse Events to Study Treatment
Hide Description [Not Specified]
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revlimid + Rituximab
Hide Arm/Group Description:

Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.

Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
25
 100.0%
3.Secondary Outcome
Title Progression Free Survival.
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Conversion of MRD-positive Complete Response or Partial Response (PR) to a MRD-negative Complete Response (CR) or Complete Response (CR) Respectively Following an Additional 6 Cycles of Revlimid Consolidation
Hide Description [Not Specified]
Time Frame 13 cycles
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Treatment Free Survival.
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Revlimid + Rituximab
Hide Arm/Group Description

Lenalidomide starting at a low dose 2.5 or 5 mg, 21 days/cycle escalated based on patient tolerability. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles (3-7). Each patient may receive up to 7 cycles of treatment with the combination lenalidomide/rituximab if no progressive disease or significant toxicity. Patients with residual disease can elect to receive 6 additional cycles of single agent Revlimid as consolidation.

Each patient may receive up to a maximum of 13 cycles of treatment if no progressive disease or significant toxicity.

All-Cause Mortality
Revlimid + Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Revlimid + Rituximab
Affected / at Risk (%) # Events
Total   11/25 (44.00%)    
Blood and lymphatic system disorders   
neutropenia   7/25 (28.00%)  9
hypophosphatemia   1/25 (4.00%)  1
Thrombocytopenia   1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Bullous arthropod reaction   1/25 (4.00%)  1
Vascular disorders   
Deep Vein Thrombosis   1/25 (4.00%)  1
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 0%
Revlimid + Rituximab
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
acidosis   5/25 (20.00%)  5
anemia   16/25 (64.00%)  26
bicarbonate decrease   1/25 (4.00%)  1
blood biliruben increase   5/25 (20.00%)  6
hematoma   1/25 (4.00%)  1
hematoma - retroperritoneal   1/25 (4.00%)  1
hemolysis   1/25 (4.00%)  1
high cholesterol   1/25 (4.00%)  1
hypercalcemia   2/25 (8.00%)  5
hyperkalemia   7/25 (28.00%)  7
hypermagnesemia   1/25 (4.00%)  1
hypernatremia   1/25 (4.00%)  2
hyperphosphatemia   12/25 (48.00%)  19
hyperuricemia   7/25 (28.00%)  15
hypoalbuminemia   8/25 (32.00%)  9
hypocalcemia   20/25 (80.00%)  30
hypokalemia   3/25 (12.00%)  6
hypomagnesemia   1/25 (4.00%)  1
hyponatremia   15/25 (60.00%)  25
hypophosphatemia   15/25 (60.00%)  23
leukopenia   1/25 (4.00%)  2
low uric acid   1/25 (4.00%)  1
neutropenia   22/25 (88.00%)  42
thrombocytopenia   20/25 (80.00%)  28
Cardiac disorders   
atrial fibrillation   2/25 (8.00%)  2
bradycardia   6/25 (24.00%)  8
palpitations   2/25 (8.00%)  2
sinus arrhythmia   1/25 (4.00%)  1
tachycardia   3/25 (12.00%)  3
ventricular arrhythmia   1/25 (4.00%)  1
Ear and labyrinth disorders   
tinnitus   1/25 (4.00%)  1
Endocrine disorders   
elevated TSH   1/25 (4.00%)  1
hypothyroidism   1/25 (4.00%)  2
Eye disorders   
blurred vision   1/25 (4.00%)  1
conjunctivitis   1/25 (4.00%)  1
retinal detachment   1/25 (4.00%)  1
right eye floater   1/25 (4.00%)  1
watering eyes   1/25 (4.00%)  1
Gastrointestinal disorders   
abdominal distension   5/25 (20.00%)  6
acid reflux   1/25 (4.00%)  1
constipation   14/25 (56.00%)  20
diarrhea   14/25 (56.00%)  27
diverticulitis   1/25 (4.00%)  1
dyspepsia   7/25 (28.00%)  7
flatulance   4/25 (16.00%)  6
gastroenteritis   1/25 (4.00%)  2
GERD   1/25 (4.00%)  1
GI Problems  [1]  1/25 (4.00%)  1
nausea   16/25 (64.00%)  23
small intestine infection   1/25 (4.00%)  1
vomiting   8/25 (32.00%)  9
General disorders   
alopecia   1/25 (4.00%)  1
bruising   4/25 (16.00%)  5
chills/rigors   15/25 (60.00%)  21
cough   18/25 (72.00%)  23
dehydration   6/25 (24.00%)  7
dry mouth   4/25 (16.00%)  4
dysphagia   2/25 (8.00%)  2
ecchymosis   4/25 (16.00%)  4
edema   13/25 (52.00%)  14
edema - eyelid   1/25 (4.00%)  1
edema - facial   1/25 (4.00%)  1
elevated LDH   5/25 (20.00%)  6
epistaxis   4/25 (16.00%)  4
fatigue   19/25 (76.00%)  28
fever   14/25 (56.00%)  18
flu-like symptoms   13/25 (52.00%)  19
flushing   1/25 (4.00%)  1
headache   8/25 (32.00%)  13
hemorrhage - oral   3/25 (12.00%)  3
hemorrhage - rectal   1/25 (4.00%)  3
hoarseness   1/25 (4.00%)  1
hot flashes   3/25 (12.00%)  6
hyperhidrosis   14/25 (56.00%)  17
insomnia   14/25 (56.00%)  23
libido decrease   1/25 (4.00%)  1
night sweats   14/25 (56.00%)  20
pain - abdominal   10/25 (40.00%)  14
pain - back   11/25 (44.00%)  18
pain - chest   4/25 (16.00%)  5
pain - chest - non-cardiac   1/25 (4.00%)  1
pain - ear   2/25 (8.00%)  2
pain - extremity   14/25 (56.00%)  19
pain - eye   1/25 (4.00%)  1
pain - facial   1/25 (4.00%)  2
pain - hip   4/25 (16.00%)  6
pain - knee   1/25 (4.00%)  1
pain - lymph node   3/25 (12.00%)  3
pain - neck   2/25 (8.00%)  3
pain - pharyngolaryngeal   12/25 (48.00%)  14
pain - rectal   1/25 (4.00%)  1
pain - ribs   1/25 (4.00%)  2
pain - right disessciata   1/25 (4.00%)  1
pain - right side   1/25 (4.00%)  1
pain - stomach   9/25 (36.00%)  12
pain - tumor   12/25 (48.00%)  16
restless leg syndrome   1/25 (4.00%)  1
rhinitis   2/25 (8.00%)  2
swelling - tongue   1/25 (4.00%)  1
syncope   2/25 (8.00%)  2
Hepatobiliary disorders   
alkaline phosphatase increase   7/25 (28.00%)  7
elevated ALT   12/25 (48.00%)  15
elevated AST   15/25 (60.00%)  16
Immune system disorders   
allergic reaction   1/25 (4.00%)  1
rhinitis - allergic rhinitis   11/25 (44.00%)  16
Infections and infestations   
bladder infection   1/25 (4.00%)  1
febrile illness   1/25 (4.00%)  1
laryngitis   1/25 (4.00%)  1
sinusitis   5/25 (20.00%)  8
Upper Respiratory Infection   13/25 (52.00%)  16
Injury, poisoning and procedural complications   
fracture   1/25 (4.00%)  1
hemorrhage - cut   1/25 (4.00%)  1
infusion reaction - cytokine release syndrome   2/25 (8.00%)  2
palmar-plantar erythrodysesthia  [2]  1/25 (4.00%)  1
tumor flare reaction  [2]  3/25 (12.00%)  5
Metabolism and nutrition disorders   
anorexia   11/25 (44.00%)  14
early satiety   3/25 (12.00%)  3
weight gain   1/25 (4.00%)  1
weight loss   15/25 (60.00%)  18
Musculoskeletal and connective tissue disorders   
arthralgia   5/25 (20.00%)  8
arthritis   2/25 (8.00%)  2
arthritis (gout big toe)   1/25 (4.00%)  1
body aches   2/25 (8.00%)  4
bursitis   1/25 (4.00%)  1
gait disturbance   2/25 (8.00%)  2
general muscle weakness   12/25 (48.00%)  18
lumbar disc disease   1/25 (4.00%)  1
myalgia   14/25 (56.00%)  22
osteopenia   2/25 (8.00%)  2
pain - abdominal/stomach - cramps  2  1/25 (4.00%)  3
tendonitis   2/25 (8.00%)  2
Nervous system disorders   
cognitive disturbance   1/25 (4.00%)  1
cognitive impairment   1/25 (4.00%)  1
confusion   2/25 (8.00%)  2
dizziness   11/25 (44.00%)  15
dysesthia   1/25 (4.00%)  1
dysgeusia   1/25 (4.00%)  1
memory impairment   3/25 (12.00%)  3
neuropathy   10/25 (40.00%)  13
neuropathy - leg and finger spasms   1/25 (4.00%)  1
pain - skin   1/25 (4.00%)  1
sciatica   1/25 (4.00%)  1
taste alteration   1/25 (4.00%)  1
tremors   3/25 (12.00%)  3
Psychiatric disorders   
depression   1/25 (4.00%)  1
psychosis   1/25 (4.00%)  1
Renal and urinary disorders   
acute renal failure   1/25 (4.00%)  1
bladder spasm   1/25 (4.00%)  1
dysuria  1  2/25 (8.00%)  2
elevated creatinine   10/25 (40.00%)  15
fluid retention   1/25 (4.00%)  1
hydronephrosis   1/25 (4.00%)  1
proteinuria   1/25 (4.00%)  1
urinary frequency   10/25 (40.00%)  12
urinary retention   2/25 (8.00%)  2
urinary tract infection   2/25 (8.00%)  2
urine discoloration   2/25 (8.00%)  2
urine odor   1/25 (4.00%)  1
Reproductive system and breast disorders   
prostatitis   2/25 (8.00%)  2
vaginal odor   1/25 (4.00%)  1
yeast (vaginal) infection   1/25 (4.00%)  3
Respiratory, thoracic and mediastinal disorders   
bronchitis   4/25 (16.00%)  4
bronchospasm/wheezing   2/25 (8.00%)  2
dyspnea   7/25 (28.00%)  7
shortness of breath   1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
canker sore   3/25 (12.00%)  5
cyst   1/25 (4.00%)  1
dry skin   4/25 (16.00%)  4
keratosis   1/25 (4.00%)  1
keratosis - actinic keratosis   1/25 (4.00%)  2
lesion   5/25 (20.00%)  5
pruritis   10/25 (40.00%)  16
rash   15/25 (60.00%)  24
skin and subcutaneous tissue disorder   1/25 (4.00%)  1
skin hyperpigmentation   5/25 (20.00%)  5
skin infection   2/25 (8.00%)  2
skin infection - cellulitis   1/25 (4.00%)  1
skin ulceration   3/25 (12.00%)  4
skin ulceration - blister on roof of mouth   1/25 (4.00%)  1
skin ulceration - finger   1/25 (4.00%)  1
ulcer - mouth   1/25 (4.00%)  1
urticaria   1/25 (4.00%)  1
Social circumstances   
anxiety   15/25 (60.00%)  29
distress   5/25 (20.00%)  5
Vascular disorders   
hypertension   4/25 (16.00%)  4
hypotension   8/25 (32.00%)  10
purpura   1/25 (4.00%)  1
superficial phlebitis   1/25 (4.00%)  1
thrombophlebitis   1/25 (4.00%)  1
thrombophlebitis - superficial   4/25 (16.00%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, burning urination
2
Term from vocabulary, abdominal cramps
[1]
Alternating constipation and diarrhea - continued through entirety of treatment.
[2]
Treatment reaction
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: Thomas Kipps, MD PhD
Organization: University of California, San Diego
Phone: 858-534-5400
EMail: tkipps@ucsd.edu
Layout table for additonal information
Responsible Party: Thomas Kipps, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01199575     History of Changes
Other Study ID Numbers: CRC022
First Submitted: August 31, 2010
First Posted: September 13, 2010
Results First Submitted: March 26, 2018
Results First Posted: October 23, 2018
Last Update Posted: July 18, 2019