A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00597519
First received: December 26, 2007
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Interventions: Drug: Fludarabine, Cyclophosphamide
Procedure: Transplantation

  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
Treatment Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy

Participant Flow:   Overall Study
    Treatment  
STARTED     28  
COMPLETED     27  
NOT COMPLETED     1  
Death                 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
Treatment Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  28  
Age  
[units: participants]
 
<=18 years     16  
Between 18 and 65 years     12  
>=65 years     0  
Gender  
[units: participants]
 
Female     12  
Male     16  



  Outcome Measures

1.  Primary:   Overall Response   [ Time Frame: 1 year ]


  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: NCT00597519     History of Changes
Obsolete Identifiers: NCT00388102
Other Study ID Numbers: 06-014
CA23766
Study First Received: December 26, 2007
Results First Received: January 14, 2016
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board