Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 107 for:    PHENYTOIN

Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders

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: NCT00801931
Recruitment Status : Terminated (Poor accrual)
First Posted : December 4, 2008
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Prakash Satwani, Columbia University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Neuroblastoma
Immunodeficiencies
Anemia
Interventions Drug: Alemtuzumab
Radiation: Total Body Irradiation
Drug: Melphalan
Drug: Busulfan
Drug: Phenytoin
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Horse Antithymocyte Globulin
Drug: Rabbit Antithymocyte Globulin
Drug: Thiotepa
Enrollment 1
Recruitment Details  
Pre-assignment Details There was only 1 subjected enrolled. The 1 subject was enrolled into Arm - Experimental: C: Moderate Intensity.
Arm/Group Title Experimental: C: Moderate Intensity
Hide Arm/Group Description Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Experimental: C: Moderate Intensity
Hide Arm/Group Description Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
There was only 1 subjected enrolled. The 1 subject was enrolled into Arm - Experimental: C: Moderate Intensity.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 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 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Graft Failure Rate
Hide Description Number of patients to experience graft failure.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects were enrolled for data analysis.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Includes all subjects in the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Response Rate (Complete and Partial Response)
Hide Description Response rate to each regimen will be measured.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects were enrolled for data analysis.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Includes all subjects in the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Overall Survival (OS)
Hide Description OS will be summarized using the Kaplan and Meier curves.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects were enrolled for data analysis.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Includes all subjects in the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Disease Free Survival (DFS)
Hide Description DFS will be summarized using the Kaplan and Meier curves.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Not enough subjects were enrolled for data analysis.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Includes all subjects in the study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: C: Moderate Intensity
Hide Arm/Group Description Patients will start their GVHD prophylaxis with Tacrolimus on Day -8. Patients will receive busulfan twice daily on Days -8, -7, -6, and -5; fludarabine on Days -7, -6, -5, -4, -3 and -2 and alemtuzumab on Days -5, -4, -3, -2, and -1. The double cord blood infusion will be performed on Day 0. GVHD prophylaxis will consist of tacrolimus/MMF.
All-Cause Mortality
Experimental: C: Moderate Intensity
Affected / at Risk (%)
Total   1/1 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: C: Moderate Intensity
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure with Cardiac Tamponade * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Led to death.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: C: Moderate Intensity
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
There was only 1 subjected enrolled. The 1 subject was enrolled into Arm - Experimental: C: Moderate Intensity.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prakash Satwani, MD
Organization: Columbia University
Phone: 212-305-0223
Responsible Party: Prakash Satwani, Columbia University
ClinicalTrials.gov Identifier: NCT00801931     History of Changes
Other Study ID Numbers: AAAC3457
CHNY-06-533 ( Other Identifier: CU )
First Submitted: May 5, 2008
First Posted: December 4, 2008
Results First Submitted: July 25, 2017
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019