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Trial record 50 of 834 for:    Texas Children's Hospital | ( Map: United States )

T-Regulatory Cell Kinetics, Stem Cell Transplantation, REGKINE (REGKINE)

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.
ClinicalTrials.gov Identifier: NCT00578461
Recruitment Status : Terminated
First Posted : December 21, 2007
Results First Posted : September 8, 2014
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
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
Cancer
Lymphoma
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Interventions Drug: Ara C
Drug: Mesna
Drug: Cyclophosphamide
Radiation: TBI-Total Body Irradiation
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description

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

Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.

Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0.

Period Title: Overall Study
Started 26
Completed 26
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 26
Hide Baseline Analysis Population Description
A total of 26 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 26 participants
9.7  (4.5)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
26
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
10
  38.5%
Male
16
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Median Percentage of Treg Cells at 1 Year Post Transplant
Hide Description The investigative intent is to determine the changes in numbers and function of the regulatory cell population using the best methods to measure this cell population. The frequency of T cells will be summarized at baseline and each time point of follow-up.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Only 20 of the 26 patients enrolled were included in this analysis as only 20 patients have Treg values at 1 year.
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description:
All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
Overall Number of Participants Analyzed 20
Median (Inter-Quartile Range)
Unit of Measure: percentage of total CD4+ cells
4.1
(3.1 to 6.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stem Cell Transplant
Hide Arm/Group Description

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

Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0.

All-Cause Mortality
Stem Cell Transplant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stem Cell Transplant
Affected / at Risk (%) # Events
Total   15/26 (57.69%)    
Cardiac disorders   
Hypertension *  1/26 (3.85%)  1
Pericardial effusion (non-malignant) *  2/26 (7.69%)  3
Gastrointestinal disorders   
Dehydration *  1/26 (3.85%)  1
General disorders   
Fever * [1]  1/26 (3.85%)  2
Death * [2]  1/26 (3.85%)  1
Pain - Abdomen NOS *  1/26 (3.85%)  1
Pain - Head/headache *  1/26 (3.85%)  1
Hepatobiliary disorders   
Liver dysfunction/failure (clinical) *  2/26 (7.69%)  3
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) *  1/26 (3.85%)  1
Infections and infestations   
Febrile neutropenia * [3]  1/26 (3.85%)  1
Infection with Grade 3 or 4 neutrophils - Catheter-related * [4]  1/26 (3.85%)  2
Infection with Grade 3 or 4 neutrophils - Vein * [5]  1/26 (3.85%)  1
Infection - Other: only clinical signs of infection *  1/26 (3.85%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood *  2/26 (7.69%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related *  5/26 (19.23%)  6
Infection with normal ANC or Grade 1 or 2 neutrophils - Nose *  1/26 (3.85%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS *  1/26 (3.85%)  1
Metabolism and nutrition disorders   
AST, SGOT * [6]  1/26 (3.85%)  1
Renal and urinary disorders   
Renal failure *  3/26 (11.54%)  4
Respiratory, thoracic and mediastinal disorders   
Hypoxia *  1/26 (3.85%)  1
Skin and subcutaneous tissue disorders   
Rash/desquamation *  1/26 (3.85%)  1
Vascular disorders   
Coagulation - Other: Severe coagulopathy *  1/26 (3.85%)  1
Portal vein flow *  1/26 (3.85%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Fever in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L
[2]
Death is not associated with CTCAE term - Multi-organ failure
[3]
Fever of unknown origin without clinically or microbiologically documented infection. ANC <1.0 x 10e9/L, fever >=38.5 degrees C.
[4]
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Catheter-related
[5]
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Vein
[6]
SGOT: serum glutamic oxaloacetic transaminase
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stem Cell Transplant
Affected / at Risk (%) # Events
Total   16/26 (61.54%)    
Gastrointestinal disorders   
Diarrhea *  4/26 (15.38%)  4
Mucositis/stomatitis (clinical exam) - Oral cavity *  3/26 (11.54%)  3
Nausea *  2/26 (7.69%)  2
Vomiting *  4/26 (15.38%)  5
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related *  3/26 (11.54%)  3
Metabolism and nutrition disorders   
ALT, SGPT * [1]  2/26 (7.69%)  2
AST, SGOT * [2]  4/26 (15.38%)  6
Bilirubin (hyperbilirubinemia) *  2/26 (7.69%)  3
Calcium, serum-low (hypocalcemia) *  2/26 (7.69%)  2
GGT * [3]  2/26 (7.69%)  2
Glucose, serum-high (hyperglycemia) *  2/26 (7.69%)  2
Sodium, serum-low (hyponatremia) *  2/26 (7.69%)  2
Vascular disorders   
PTT * [4]  2/26 (7.69%)  3
*
Indicates events were collected by non-systematic assessment
[1]
SGPT: serum glutamic pyruvic transaminase
[2]
SGOT: serum glutamic oxaloacetic transaminase
[3]
GGT: gamma-Glutamyl transpeptidase
[4]
PTT: Partial Thromboplastin Time
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
Responsible Party: Robert Krance, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578461     History of Changes
Obsolete Identifiers: NCT00653289
Other Study ID Numbers: H-19164 REGKINE
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