Cellular Therapy With Cord Blood Cells

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00427557
First received: January 25, 2007
Last updated: May 23, 2012
Last verified: May 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Leukemia
Lymphoma
Interventions: Drug: Fludarabine
Drug: Melphalan
Procedure: Umbilical Cord Blood
Drug: Rituximab
Other: Peripheral Blood Stem Cell Infusion

  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
Recruitment Period: January 05, 2007 to November 05, 2010. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant of the 31 was enrolled but did not receive treatment.

Reporting Groups
  Description
Cellular Therapy With Cord Blood Cells Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Participant Flow:   Overall Study
    Cellular Therapy With Cord Blood Cells  
STARTED     30  
COMPLETED     30  
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.
No text entered.

Reporting Groups
  Description
Cellular Therapy With Cord Blood Cells Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion

Baseline Measures
    Cellular Therapy With Cord Blood Cells  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 17  
Gender  
[units: participants]
 
Female     11  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures

1.  Primary:   Number of Participants With Engraftment   [ Time Frame: Baseline to 100 days post-engraftment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Partow Kebriaei
Organization: MD Anderson Cancer Center
phone: 713-563-5174
e-mail: celsaenz@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427557     History of Changes
Other Study ID Numbers: 2006-0553
Study First Received: January 25, 2007
Results First Received: April 19, 2012
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board