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T-Reg Cell Kinetics, Stem Cell Transplant, REGALE

This study has been terminated.
Sponsor:
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine
Texas Children's Hospital
Information provided by (Responsible Party):
Robert Krance, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00578539
First received: December 19, 2007
Last updated: August 28, 2014
Last verified: August 2014
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Myeloproliferative Disorders
Interventions: Drug: ARA C
Drug: Cyclophosphamide
Drug: MESNA
Radiation: Total Body Irradiation (TBI)
Biological: Campath-1h
Procedure: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stem Cell Transplant All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.

Participant Flow:   Overall Study
    Stem Cell Transplant  
STARTED     24  
COMPLETED     24  
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.
A total of 24 patients were enrolled on the study and all of them received the conditioning treatment and the transplant.

Reporting Groups
  Description
Stem Cell Transplant All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.

Baseline Measures
    Stem Cell Transplant  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  10.0  ± 4.9  
Age  
[units: participants]
 
<=18 years     23  
Between 18 and 65 years     1  
>=65 years     0  
Gender  
[units: participants]
 
Female     7  
Male     17  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures

1.  Primary:   Median Percentage of Treg Cells at 1 Year Post Transplant   [ 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: Robert Krance, MD
Organization: Baylor College of Medicine
phone: 832-824-4661
e-mail: rakrance@txch.org


No publications provided by Baylor College of Medicine

Publications automatically indexed to this study:

Responsible Party: Robert Krance, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578539     History of Changes
Obsolete Identifiers: NCT00647010
Other Study ID Numbers: H-21079-REGALE, REGALE
Study First Received: December 19, 2007
Results First Received: August 28, 2014
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration