T-Reg Cell Kinetics, Stem Cell Transplant, REGALE (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: March 24, 2016

Last verified: March 2016

History of Changes

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
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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
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.

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 ]

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Serious Adverse Events

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Other Adverse Events

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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

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

Cohen JI, Jaffe ES, Dale JK, Pittaluga S, Heslop HE, Rooney CM, Gottschalk S, Bollard CM, Rao VK, Marques A, Burbelo PD, Turk SP, Fulton R, Wayne AS, Little RF, Cairo MS, El-Mallawany NK, Fowler D, Sportes C, Bishop MR, Wilson W, Straus SE. Characterization and treatment of chronic active Epstein-Barr virus disease: a 28-year experience in the United States. Blood. 2011 Jun 2;117(22):5835-49. doi: 10.1182/blood-2010-11-316745. Epub 2011 Mar 31.

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:	March 24, 2016
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

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