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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:
Collaborator:
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Robert Krance, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: N/A;   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
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
A total of 24 patients were enrolled on the study and all of them received the conditioning treatment and the transplant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
10.0  (4.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
23
  95.8%
Between 18 and 65 years
1
   4.2%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
7
  29.2%
Male
17
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Median Percentage of Treg Cells at 1 Year Post Transplant
Hide Description To define the biologic recovery and behavior of T regulatory cells for patients undergoing stem cell transplantation as specified in this protocol
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Only 13 of the 24 patients enrolled were included in this analysis as only 13 patients have Treg values at 1 year.
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: percentage of total CD4+ cells
6.9
(4.6 to 13.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description 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.
All-Cause Mortality
Stem Cell Transplant
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Stem Cell Transplant
Affected / at Risk (%) # Events
Total   17/24 (70.83%)    
Blood and lymphatic system disorders   
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) *  1/24 (4.17%)  1
Cardiac disorders   
Cardiopulmonary arrest, cause unknown (non-fatal) *  1/24 (4.17%)  2
Pericardial effusion (non-malignant) *  2/24 (8.33%)  2
General disorders   
Death * [1]  1/24 (4.17%)  1
Pain - Abdomen NOS *  1/24 (4.17%)  1
Hepatobiliary disorders   
Liver dysfunction/failure (clinical) *  1/24 (4.17%)  1
Infections and infestations   
Infection with Grade 3 or 4 neutrophils - Bladder (urinary) * [2]  1/24 (4.17%)  1
Infection with Grade 3 or 4 neutrophils - Blood *  3/24 (12.50%)  4
Infection with Grade 3 or 4 neutrophils - Bronchus *  1/24 (4.17%)  1
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia) *  1/24 (4.17%)  1
Infection with Grade 3 or 4 neutrophils - Urinary tract NOS *  1/24 (4.17%)  1
Infection - Other: Multiple viral infections *  1/24 (4.17%)  1
Infection - Other: Probable fungal disease *  1/24 (4.17%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS *  2/24 (8.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) *  3/24 (12.50%)  6
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood *  3/24 (12.50%)  4
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related *  2/24 (8.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper aerodigestive NOS *  2/24 (8.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS *  2/24 (8.33%)  3
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS *  1/24 (4.17%)  1
Metabolism and nutrition disorders   
AST, SGOT * [3]  2/24 (8.33%)  2
Nervous system disorders   
Neurology - Other: Aseptic meningitis *  1/24 (4.17%)  1
Neurology - Other: Cranial nerve VI palsy *  1/24 (4.17%)  1
Neurology - Other: Peripheral neuropathy *  1/24 (4.17%)  1
Renal and urinary disorders   
Cystitis *  1/24 (4.17%)  1
Renal failure *  3/24 (12.50%)  3
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS *  1/24 (4.17%)  1
Hypoxia *  1/24 (4.17%)  1
Pleural effusion (non-malignant) *  1/24 (4.17%)  1
Pulmonary/Upper Respiratory - Other: Acute respiratory failure *  1/24 (4.17%)  1
Pulmonary/Upper Respiratory - Other: Respiratory distress: dyspnea + hypoxia *  1/24 (4.17%)  1
Pulmonary/Upper Respiratory - Other: Respiratory failure *  1/24 (4.17%)  1
Skin and subcutaneous tissue disorders   
Rash/desquamation *  1/24 (4.17%)  1
Vascular disorders   
Vascular - Other: Vaso Oclusive Disease *  1/24 (4.17%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Death not associated with CTCAE term - Multi-organ failure
[2]
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Bladder (urinary)
[3]
SGOT: serum glutamic oxaloacetic transaminase
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stem Cell Transplant
Affected / at Risk (%) # Events
Total   13/24 (54.17%)    
Cardiac disorders   
Hypotension *  2/24 (8.33%)  2
Gastrointestinal disorders   
Diarrhea *  2/24 (8.33%)  3
Mucositis/stomatitis (clinical exam) * [1]  4/24 (16.67%)  5
Nausea *  3/24 (12.50%)  3
Vomiting *  3/24 (12.50%)  3
Infections and infestations   
Infection - Other: CMV viremia *  2/24 (8.33%)  2
Infection with Grade 3 or 4 neutrophils - Blood *  2/24 (8.33%)  2
Metabolism and nutrition disorders   
AST, SGOT * [2]  2/24 (8.33%)  2
Renal and urinary disorders   
Renal failure *  2/24 (8.33%)  2
Vascular disorders   
PTT * [3]  2/24 (8.33%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Two events were specified as oral cavity
[2]
SGOT: serum glutamic oxaloacetic transaminase
[3]
PTT: Partial Thromboplastin Time
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Krance, MD
Organization: Baylor College of Medicine
Phone: 832-824-4661
EMail: rakrance@txch.org
Layout table for additonal information
Responsible Party: Robert Krance, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578539    
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