T-Reg Cell Kinetics, Stem Cell Transplant, REGALE (REGALE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00578539
Recruitment Status : Terminated
First Posted : December 21, 2007
Results First Posted : September 8, 2014
Last Update Posted : April 22, 2016
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Hodgkin Lymphoma
Non Hodgkin Lymphoma
Myeloproliferative Disorders
Interventions: Drug: ARA C
Drug: Cyclophosphamide
Radiation: Total Body Irradiation (TBI)
Biological: Campath-1h
Procedure: Stem Cell Infusion

  Participant Flow

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
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

  Baseline Characteristics

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

Baseline Measures
   Stem Cell Transplant 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 10.0  (4.9) 
[Units: Participants]
<=18 years   23 
Between 18 and 65 years   1 
>=65 years   0 
[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

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.

  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Robert Krance, Baylor College of Medicine Identifier: NCT00578539     History of Changes
Obsolete Identifiers: NCT00647010
Other Study ID Numbers: H-21079-REGALE
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: August 28, 2014
Results First Posted: September 8, 2014
Last Update Posted: April 22, 2016