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Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00648037
First received: March 27, 2008
Last updated: December 29, 2015
Last verified: December 2015
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hodgkin's Disease
Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Intervention: Drug: Rituximab

  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
Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT

Participant Flow:   Overall Study
    Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT  
STARTED     26  
COMPLETED     10  
NOT COMPLETED     16  
Not Treated                 1  
Withdrawal by Subject                 1  
Adverse Event                 11  
Relapse                 2  
Unknown                 1  



  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
Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLA mismatched related HSCT

Baseline Measures
    Rituximab Prophylaxis in TCD Unrelated or HLA Mismatched HSCT  
Number of Participants  
[units: participants]
  26  
Age  
[units: participants]
 
<=18 years     9  
Between 18 and 65 years     16  
>=65 years     1  
Gender  
[units: participants]
 
Female     9  
Male     17  



  Outcome Measures

1.  Primary:   Safety of Rituximab Prophylaxis   [ Time Frame: 3 months post transplant ]


  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: Papadopoulos, Esperanza, MD (Attending)
Organization: Memorial Sloan Kettering Cancer Center
phone: +1212-639-8276
e-mail: papadope@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00648037     History of Changes
Other Study ID Numbers: 01-118
Study First Received: March 27, 2008
Results First Received: October 20, 2015
Last Updated: December 29, 2015
Health Authority: United States: Food and Drug Administration