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

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ClinicalTrials.gov Identifier: NCT00578539

Recruitment Status : Terminated

First Posted : December 21, 2007

Results First Posted : September 8, 2014

Last Update Posted : April 22, 2016

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

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 Drug: MESNA Radiation: Total Body Irradiation (TBI) Biological: Campath-1h Procedure: Stem Cell Infusion

Participant Flow

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Recruitment Details

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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
Overall Participants Analyzed [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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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
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

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