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LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610883
First Posted: February 8, 2008
Last Update Posted: January 25, 2016
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.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: December 21, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Intervention: Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Patients LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance

Participant Flow:   Overall Study
    All Patients
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Patients LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age, Customized 
[Units: Years]
Median (Full Range)
 
Median Age   12 
 (2 to 19) 
Gender 
[Units: Participants]
 
Female   5 
Male   12 


  Outcome Measures

1.  Primary:   Complete Remission   [ Time Frame: 330 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Tanya Trippett
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-8267
e-mail: trippet1@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00610883     History of Changes
Other Study ID Numbers: 90-042
First Submitted: December 26, 2007
First Posted: February 8, 2008
Results First Submitted: December 21, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016