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5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00413478
Recruitment Status : Terminated (Slow accrual.)
First Posted : December 19, 2006
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson 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: 5-Azacytidine
Enrollment 9
Recruitment Details Recruitment Period: 09/21/2006 to 12/01/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details The study was discontinued after 9 participants enrolled because of lack of efficacy and slow accrual.
Arm/Group Title 5-Azacytidine
Hide Arm/Group Description 5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title 5-Azacytidine
Hide Arm/Group Description 5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
74
(49 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Tumor Response Rate (Complete, Partial) of Azacytidine
Hide Description Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count > 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be > 11g/dl without transfusions. Lymphocyte count <4000/micL. On bone marrow aspirate lymphocyte % should be <30%, and biopsy showing no lymphocyte infiltrate. A partial response was defined as more than or equal to 50% decrease in lymph nodes and liver and spleen size. Neutrophils > 1500/ micL or >50 % improvement from baseline, platelet count >100,000/micL or >50 % improvement from baseline. Hemoglobin >11g/dl or >50% improvement from baseline. A reduction of >50% in Leukocyte count or <30 % lymphocytes with residual disease on biopsy for nodular PR.
Time Frame 3 to 8 weeks treatment cycles, continuation up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 5-Azacytidine
Hide Arm/Group Description:
5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame Adverse event data collected with each 7 day treatment through subsequent repeated treatment cycles every 3 to 8 weeks with continuation up to 1 year. Overall collection period: October 2006 to August 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5-Azacytidine
Hide Arm/Group Description 5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
All-Cause Mortality
5-Azacytidine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
5-Azacytidine
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5-Azacytidine
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/9 (11.11%) 
Anemia  1  1/9 (11.11%) 
Neutropenia  1  3/9 (33.33%) 
Hematoma  1  1/9 (11.11%) 
Cardiac disorders   
Arrythmia  1  1/9 (11.11%) 
Eye disorders   
blurry vision  1  1/9 (11.11%) 
Gastrointestinal disorders   
Diarrhea  1  2/9 (22.22%) 
Vomiting  1  2/9 (22.22%) 
Constipation  1  1/9 (11.11%) 
Nausea  1  3/9 (33.33%) 
weight loss  1  1/9 (11.11%) 
General disorders   
Fever  1  2/9 (22.22%) 
fatigue  1  1/9 (11.11%) 
headache  1  1/9 (11.11%) 
lightheadedness  1  1/9 (11.11%) 
Pain  1  1/9 (11.11%) 
Sweats  1  1/9 (11.11%) 
swollen lips  1  1/9 (11.11%) 
Infections and infestations   
Infections  1  6/9 (66.67%) 
Pneumonia  1  3/9 (33.33%) 
Cellulitis  1  1/9 (11.11%) 
MRSA Infection  1  1/9 (11.11%) 
Neutropenic fever  1  1/9 (11.11%) 
Pulmonary Infiltrates  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Hypomagnesia  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
cramps  1  1/9 (11.11%) 
Nervous system disorders   
Bells Palsy  1  1/9 (11.11%) 
Renal and urinary disorders   
dysuria  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/9 (22.22%) 
pleural effusion  1  1/9 (11.11%) 
Shortness of breath  1  3/9 (33.33%) 
Skin and subcutaneous tissue disorders   
Skin Rash  1  3/9 (33.33%) 
Erythema  1  1/9 (11.11%) 
Vascular disorders   
Edema  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Early termination led to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Zeev Estrov, MD/Professor, Leukemia
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-794-1675
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00413478     History of Changes
Other Study ID Numbers: 2006-0428
NCI-2010-00552 ( Registry Identifier: NCI CTRP )
First Submitted: December 15, 2006
First Posted: December 19, 2006
Results First Submitted: June 3, 2015
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015