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Trial record 10 of 179 for:    LENALIDOMIDE AND Leukemia

Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01600053
Recruitment Status : Terminated (interim analysis showed that the trial will not meet the interim endpoint.)
First Posted : May 16, 2012
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
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
Condition Chronic Lymphocytic Leukemia
Intervention Drug: Lenalidomide
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide
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Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

Period Title: Overall Study
Started 11
Completed 0
Not Completed 11
Reason Not Completed
Adverse Event             2
trial will not meet the interim endpoint             9
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  45.5%
>=65 years
6
  54.5%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Eradication of Residual Disease From the Marrow
Hide Description [Not Specified]
Time Frame From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Recording of the Occurrence of Adverse Events
Hide Description [Not Specified]
Time Frame From date of first dose until the date of first documented progression or date of death from any cause, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles

Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.

All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
neutropenia   9/11 (81.82%)  10
anemia   3/11 (27.27%)  3
thrombocytopenia   9/11 (81.82%)  9
Eye disorders   
eye pain   2/11 (18.18%)  2
blurred vision   1/11 (9.09%)  1
dry eyes   1/11 (9.09%)  1
Gastrointestinal disorders   
dysphagia   1/11 (9.09%)  1
diarrhea   7/11 (63.64%)  7
constipation   4/11 (36.36%)  4
colitis   1/11 (9.09%)  1
rectal hemorrhage   1/11 (9.09%)  1
nausea   2/11 (18.18%)  2
stomach pain   1/11 (9.09%)  1
abdominal distension   1/11 (9.09%)  1
dyspepsia   3/11 (27.27%)  3
General disorders   
cough   6/11 (54.55%)  6
non-cardiac chest pain   1/11 (9.09%)  1
fever   1/11 (9.09%)  1
fatigue   5/11 (45.45%)  5
Infections and infestations   
conjunctivitis   1/11 (9.09%)  1
sinusiitis   2/11 (18.18%)  2
URI   3/11 (27.27%)  3
small intestine infection   1/11 (9.09%)  1
Investigations   
elevated AST   2/11 (18.18%)  2
elevated ALT   6/11 (54.55%)  6
elevated creatine   1/11 (9.09%)  1
weight loss   1/11 (9.09%)  1
Metabolism and nutrition disorders   
hypocalcemia   4/11 (36.36%)  4
hyponatremia   6/11 (54.55%)  6
hypokalemia   1/11 (9.09%)  1
hyperphosphatemia   2/11 (18.18%)  2
hypomagnesium   5/11 (45.45%)  5
hypoalbuminemia   1/11 (9.09%)  1
hypophosphatemia   2/11 (18.18%)  2
hypercalcemia   1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
arthralgia   2/11 (18.18%)  2
muscle weakness   2/11 (18.18%)  2
pain in extremity   2/11 (18.18%)  2
myalgia   2/11 (18.18%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
tumor pain   3/11 (27.27%)  3
Nervous system disorders   
headache   4/11 (36.36%)  4
neuropathy   4/11 (36.36%)  4
tremors   2/11 (18.18%)  2
dizziness   1/11 (9.09%)  1
Renal and urinary disorders   
urinary frequency   1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
throat pain   1/11 (9.09%)  1
pneumonia   1/11 (9.09%)  1
allergic rhinitis   1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
rash   5/11 (45.45%)  5
pruritis   4/11 (36.36%)  4
dry skin   1/11 (9.09%)  1
skin ulceration   1/11 (9.09%)  1
hyperhidrosis   1/11 (9.09%)  1
Vascular disorders   
hypertension   1/11 (9.09%)  1
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: Thomas Kipps, MD
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: NCT01600053     History of Changes
Other Study ID Numbers: 101955
First Submitted: May 9, 2012
First Posted: May 16, 2012
Results First Submitted: December 16, 2015
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016