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Trial record 19 of 92 for:    CLL [CONDITION] Lenalidomide [TREATMENT]

Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

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ClinicalTrials.gov Identifier: NCT01011894
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Leukemia
Intervention Drug: lenalidomide
Enrollment 26

Recruitment Details Protocol Open to Accrual 11/6/2009, Protocol Closed to Accrual 2/26/2013, Primary Completion Date 2/23/2016, Recruitment location is the medical clinic
Pre-assignment Details  
Arm/Group Title Intermediate or High Risk Chronic Lymphocytic Leukemia
Hide Arm/Group Description This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
Period Title: Overall Study
Started 26
Completed 26
Not Completed 0
Arm/Group Title Intermediate or High Risk Chronic Lymphocytic Leukemia
Hide Arm/Group Description This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
26
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
9
  34.6%
Male
17
  65.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 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
2
   7.7%
White
24
  92.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Best Response
Hide Description The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC >/= 1,500/ul, platelets> 100,000/ul, Hgb>11gm/dl (untransfused); Partial Response (PR): >50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in size of the liver and/or the spleen; Progressive Disease (PD): Characterized by at least one of the following: > 50% increase in the sum of the products of at least 2 lymph nodes on at least 2 consecutive exams at least 2 weeks apart. At least 1 node must be >/= to 2cm in size, Appearance of new palpable LN, > 50% increase in size of liver or spleen determined by measurement below the respective costal
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
20 participants had Stable Disease, 3 had Progression of Disease, 3 were not evaluable due to toxicity
Arm/Group Title Participants Receiving Lenalidomide
Hide Arm/Group Description:
Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Stable Disease
20
  76.9%
Progressive Disease
3
  11.5%
Not Evaluable
3
  11.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intermediate or High Risk Chronic Lymphocytic Leukemia
Hide Arm/Group Description This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
All-Cause Mortality
Intermediate or High Risk Chronic Lymphocytic Leukemia
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intermediate or High Risk Chronic Lymphocytic Leukemia
Affected / at Risk (%)
Total   11/26 (42.31%) 
Blood and lymphatic system disorders   
ALT, SGPT  1  1/26 (3.85%) 
Platelet count decreased  1  1/26 (3.85%) 
Cardiac disorders   
Thrombosis/thrombus/embolism  1  1/26 (3.85%) 
General disorders   
Dizziness  1  1/26 (3.85%) 
Fatigue  1  3/26 (11.54%) 
Febrile neutropenia  1  1/26 (3.85%) 
Headache  1  1/26 (3.85%) 
Pneumonia  1  4/26 (15.38%) 
Metabolism and nutrition disorders   
Creatinine increased  1  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Lung infection  1  3/26 (11.54%) 
Skin and subcutaneous tissue disorders   
Skin infection  1  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intermediate or High Risk Chronic Lymphocytic Leukemia
Affected / at Risk (%)
Total   26/26 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  3/26 (11.54%) 
Investigations   
Neutrophil count decreased  1  19/26 (73.08%) 
Platelet count decreased  1  10/26 (38.46%) 
Aspartate aminotransferase increased  1  4/26 (15.38%) 
Alanine aminotransferase increased  1  3/26 (11.54%) 
INR increased  1  2/26 (7.69%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  3/26 (11.54%) 
Hypophosphatemia  1  2/26 (7.69%) 
Hyperkalemia  1  2/26 (7.69%) 
Vascular disorders   
Thromboembolic event  1  2/26 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Renier Brentjens
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-7053
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01011894     History of Changes
Other Study ID Numbers: 09-045
First Submitted: November 9, 2009
First Posted: November 11, 2009
Results First Submitted: February 23, 2017
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017