Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00608517
First received: January 31, 2008
Last updated: May 9, 2012
Last verified: May 2012
Results First Received: October 11, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions: Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methylprednisolone
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
Recruitment period = 9/23/2005 through 8/15/2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 7 people signed consent to take part in this study. Of those, 1 was determined to be ineligible.

Reporting Groups
  Description
Pediatric Myeloablative Conditioning Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Adult Myeloablative Conditioning Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Reduced-intensity Conditioning Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.

Participant Flow:   Overall Study
    Pediatric Myeloablative Conditioning     Adult Myeloablative Conditioning     Reduced-intensity Conditioning  
STARTED     2     3     1  
COMPLETED     1     3     1  
NOT COMPLETED     1     0     0  
Death                 1                 0                 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
Pediatric Myeloablative Conditioning Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
Adult Myeloablative Conditioning Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
Reduced-intensity Conditioning Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
Total Total of all reporting groups

Baseline Measures
    Pediatric Myeloablative Conditioning     Adult Myeloablative Conditioning     Reduced-intensity Conditioning     Total  
Number of Participants  
[units: participants]
  2     3     1     6  
Age  
[units: participants]
       
<=18 years     2     0     0     2  
Between 18 and 65 years     0     3     1     4  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  8  ± 1     31  ± 1     42  ± 1     31  ± 1  
Gender  
[units: participants]
       
Female     1     1     1     3  
Male     1     2     0     3  
Region of Enrollment  
[units: participants]
       
United States     2     3     1     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With 100-day Non-relapse Mortality   [ Time Frame: 100 days ]

2.  Secondary:   Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells   [ Time Frame: 42 days ]

3.  Secondary:   Number of Participants With Acute Graft-versus-host Disease (GVHD)   [ Time Frame: 100 days ]

4.  Secondary:   Number of Participants Who Relapsed at 1 Year   [ Time Frame: 1 year ]

5.  Secondary:   Number of Subjects With All-cause Mortality   [ Time Frame: at 100 days ]

6.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

7.  Secondary:   Number of Participants With Chronic Graft Versus Host Disease (GVHD)   [ Time Frame: 100 days ]


  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: Brian Engelhardt, M.D.
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-1803


No publications provided


Responsible Party: Brian Engelhardt, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00608517     History of Changes
Obsolete Identifiers: NCT00244036
Other Study ID Numbers: VICC BMT 0552, VU-VICC-BMT-0552
Study First Received: January 31, 2008
Results First Received: October 11, 2010
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration