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Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

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ClinicalTrials.gov Identifier: NCT00582894
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : April 22, 2011
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
University of Oklahoma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hematological Neoplasms
Hematopoietic Stem Cell Transplantation
Intervention Drug: Busulfex, Fludarabine, ALemtuzumab
Enrollment 17
Recruitment Details Recruitment began February 2005 and concluded around March 2007
Pre-assignment Details  
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Period Title: Overall Study
Started 17
Day 100 Post Transplant 17
Completed 17
Not Completed 0
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
51.8  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
3
  17.6%
Male
14
  82.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Number of Participants Experiencing Transplant Related Mortality (TRM)
Hide Description [Not Specified]
Time Frame At Day 100 post trans-plant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description:
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
0
2.Primary Outcome
Title Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
Hide Description [Not Specified]
Time Frame At time of study termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description:
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
17
3.Secondary Outcome
Title Number of Participants Relapse-Free
Hide Description [Not Specified]
Time Frame 100 days post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Last observation carried forward
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description:
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
5
4.Secondary Outcome
Title Number of Participants Overall Survival as a Function of Time.
Hide Description [Not Specified]
Time Frame 100 days post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Last observation carried forward
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description:
Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
11
Time Frame Day 100 Post Transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reduced Intensity Regimen
Hide Arm/Group Description Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
All-Cause Mortality
Reduced Intensity Regimen
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reduced Intensity Regimen
Affected / at Risk (%) # Events
Total   1/17 (5.88%)    
Vascular disorders   
Intracranial hemorrhage - recurrence * 1 [1]  1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Source Vocabulary
[1]
Event determined to be "not related" to study participation; resulted in death of participant
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Reduced Intensity Regimen
Affected / at Risk (%) # Events
Total   4/17 (23.53%)    
Blood and lymphatic system disorders   
Positive Cytomegalovirus cultures * 1 [1]  1/17 (5.88%)  1
Thrombocytopenia * 1 [2]  1/17 (5.88%)  1
Blasts in bone marrow * 1 [3]  1/17 (5.88%)  1
General disorders   
Syncopal episode / Hypotension * 1 [4]  1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Source Vocabulary
[1]
Hospitalized for treatment and recovered without sequelae
[2]
Hospitalized and recovered without sequelae
[3]
Determined to be not related to study participation; recovered without sequelae
[4]
Determined to be "not related" to study participation; recovered without sequelae
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: George Selby, MD
Organization: University of Oklahoma Health Sciences Center
Phone: 405/271-4022
EMail: george-selby@ouhsc.edu
Layout table for additonal information
Responsible Party: George Selby, MD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00582894     History of Changes
Other Study ID Numbers: Reduced-Intensity
IRB #11835 ( Other Identifier: University of Oklahoma Health Sciences Center )
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: January 10, 2011
Results First Posted: April 22, 2011
Last Update Posted: April 22, 2011