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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00610883
First received: December 26, 2007
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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
Study First Received: December 26, 2007
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board