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Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00453206
First received: March 27, 2007
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: May 28, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Interventions: Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant

Participant Flow:   Overall Study
    Reduced Intensity Allogeneic Cell Transplantation
STARTED   66 
COMPLETED   65 
NOT COMPLETED   1 
Death                1 



  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.
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Reporting Groups
  Description
Reduced Intensity Allogeneic Cell Transplantation reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant

Baseline Measures
   Reduced Intensity Allogeneic Cell Transplantation 
Overall Participants Analyzed 
[Units: Participants]
 66 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (7.5) 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      48  72.7% 
>=65 years      18  27.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  31.8% 
Male      45  68.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   3.0% 
White      64  97.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   1.5% 
Not Hispanic or Latino      65  98.5% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   66 


  Outcome Measures

1.  Primary:   Treatment-related Mortality Within the First 6 Months After Transplantation   [ Time Frame: 6 months ]

2.  Secondary:   Complete Response   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Overall Survival   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Disease-free Survival   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Graft-versus-host Disease   [ Time Frame: monthly ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Iron Status at the Time of Transplantation   [ Time Frame: baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Quality of Life at the Time of Transplantation   [ Time Frame: baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Treatment-related Mortality at 100 Days After Transplantation   [ Time Frame: 100 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
By the time the primary objective of this trial was completed, the treatment approach of the trial had become standard of care. Analysis was therefore limited.


  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: David Hurd, MD
Organization: Wake Forest University Health Sciences
phone: 336-716-2843
e-mail: dhurd@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00453206     History of Changes
Other Study ID Numbers: CDR0000538185
CCCWFU-29506 ( Other Identifier: CCCWFU )
IRB00001366 ( Other Identifier: WFUHS IRB )
Study First Received: March 27, 2007
Results First Received: May 28, 2014
Last Updated: February 21, 2017