Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00387959
First received: October 12, 2006
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation

  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
Unrelated Donor Umbilical Cord Transplant Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood

Participant Flow:   Overall Study
    Unrelated Donor Umbilical Cord Transplant  
STARTED     17  
COMPLETED     16  
NOT COMPLETED     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
Unrelated Donor Umbilical Cord Transplant Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood

Baseline Measures
    Unrelated Donor Umbilical Cord Transplant  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     1  
Gender  
[units: participants]
 
Female     5  
Male     12  



  Outcome Measures

1.  Primary:   Survival at 1 Year After Transplantation   [ Time Frame: 1 Year after 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: Dr. Juliet Barker
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-3468
e-mail: barkerj@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00387959     History of Changes
Other Study ID Numbers: 06-066
MSKCC-06066
Study First Received: October 12, 2006
Results First Received: December 22, 2015
Last Updated: December 22, 2015
Health Authority: United States: Food and Drug Administration