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Treatment of Adult Ph+ LAL With BMS-354825

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00391989
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : January 26, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoblastic Leukemia, Acute
Intervention Drug: Dasatinib
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Group
Hide Arm/Group Description All patients registered in the study.
Period Title: Overall Study
Started 55
Completed 53
Not Completed 2
Arm/Group Title Dasatinib
Hide Arm/Group Description All patients registered in the study.
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 53 participants
53.61
(23.79 to 76.49)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
27
  50.9%
Male
26
  49.1%
White Blood Cells  
Median (Full Range)
Unit of measure:  *10^9 cells/L
Number Analyzed 53 participants
18.80
(2.20 to 132.90)
1.Primary Outcome
Title Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).
Hide Description [Not Specified]
Time Frame End of the study, up to day 85
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
All patients registered in the study.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: Patients
53
2.Secondary Outcome
Title The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
4.Secondary Outcome
Title the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
6.Secondary Outcome
Title the Cumulative Incidence of Relapse;
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
7.Secondary Outcome
Title OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.
Hide Description [Not Specified]
Time Frame End of study
Outcome Measure Data Not Reported
Time Frame 25 months.
Adverse Event Reporting Description Physicians reporting whenever a SAE happened.
 
Arm/Group Title Dasatinib
Hide Arm/Group Description All patients registered in the study.
All-Cause Mortality
Dasatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dasatinib
Affected / at Risk (%) # Events
Total   13/53 (24.53%)    
Gastrointestinal disorders   
Gastrointestinal toxicity *  1/53 (1.89%) 
Infection *  1/53 (1.89%) 
General disorders   
Weight gain *  1/53 (1.89%) 
Diarrhea *  1/53 (1.89%) 
Hypertransaminasemia *  1/53 (1.89%) 
Fever *  1/53 (1.89%) 
Proteinuria *  1/53 (1.89%) 
Increase of liver function *  1/53 (1.89%) 
Mood alteration *  1/53 (1.89%) 
hyperkalemia *  1/53 (1.89%) 
Nausea *  2/53 (3.77%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary edema *  1/53 (1.89%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dasatinib
Affected / at Risk (%) # Events
Total   12/53 (22.64%)    
Gastrointestinal disorders   
Gastrointestinal *  1/53 (1.89%) 
General disorders   
Fever *  1/53 (1.89%) 
Weight gain *  1/53 (1.89%) 
proteinuria *  1/53 (1.89%) 
Mild increase of liver function *  2/53 (3.77%) 
Infection *  1/53 (1.89%) 
Mood alteration *  1/53 (1.89%) 
Hyperkalemia *  1/53 (1.89%) 
Acute pulmonary edema *  1/53 (1.89%) 
Diarrhea *  1/53 (1.89%) 
Hypertransaminasemia *  1/53 (1.89%) 
Nausea *  1/53 (1.89%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Paola Fazy; Dr. Marco Vignetti
Organization: GIMEMA
Phone: +39 06.70390521
EMail: gimema@gimema.it
Layout table for additonal information
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00391989     History of Changes
Other Study ID Numbers: LAL1205
First Submitted: October 24, 2006
First Posted: October 25, 2006
Results First Submitted: January 23, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 4, 2017