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Three Immunosuppressive Treatment Regimens for Severe Aplastic Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT00260689
First received: December 1, 2005
Last updated: May 16, 2017
Last verified: May 15, 2017
Results First Received: May 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Immunosuppresion
Thrombocytopenia
Pancytopenia
Neutropenia
Interventions: Biological: Anti-thymocyte globulin (rabbit)
Biological: Anti-thymocyte globulin (horse)
Drug: Cyclosporine
Drug: Alemtuzumab

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Horse ATG/CsA Taper Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
Rabbit ATG/CsA Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
Alemtuzumab Alemtuzumab (Campath) administered for 10 days

Participant Flow:   Overall Study
    Horse ATG/CsA Taper   Rabbit ATG/CsA   Alemtuzumab
STARTED   60   60   16 
COMPLETED   19   11   1 
NOT COMPLETED   41   49   15 



  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.
No text entered.

Reporting Groups
  Description
Horse ATG/CsA Taper Horse Anti-thymocyte Globulin (h-ATG) + 6 months Cyclosporine (CsA) followed by an 18 month CsA taper
Rabbit ATG/CsA Rabbit Anti-thymocyte Globulin (r-ATG) + 6 months Cyclosporine (CsA)
Alemtuzumab Alemtuzumab (Campath) administered for 10 days
Total Total of all reporting groups

Baseline Measures
   Horse ATG/CsA Taper   Rabbit ATG/CsA   Alemtuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   60   16   136 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      14  23.3%      21  35.0%      4  25.0%      39  28.7% 
Between 18 and 65 years      38  63.3%      35  58.3%      8  50.0%      81  59.6% 
>=65 years      8  13.3%      4   6.7%      4  25.0%      16  11.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      27  45.0%      23  38.3%      4  25.0%      54  39.7% 
Male      33  55.0%      37  61.7%      12  75.0%      82  60.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      9  15.0%      13  21.7%      7  43.8%      29  21.3% 
Not Hispanic or Latino      50  83.3%      44  73.3%      9  56.3%      103  75.7% 
Unknown or Not Reported      1   1.7%      3   5.0%      0   0.0%      4   2.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      5   8.3%      2   3.3%      1   6.3%      8   5.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      15  25.0%      20  33.3%      1   6.3%      36  26.5% 
White      29  48.3%      24  40.0%      7  43.8%      60  44.1% 
More than one race      2   3.3%      0   0.0%      0   0.0%      2   1.5% 
Unknown or Not Reported      9  15.0%      14  23.3%      7  43.8%      30  22.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hematologic Response   [ Time Frame: 3 months ]

2.  Primary:   Hematologic Response   [ Time Frame: 6 months ]

3.  Primary:   Hematologic Response   [ Time Frame: 12 months ]


  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
Originally, there were 3 regimens: h-ATG/CsA ; r-ATG/CsA; alemtuzumab. Subjects not responding to r-ATG will cross over to alemtuzumab, and subjects failing alemtuzumab will cross over to r-ATG. Subjects not responding to h-ATG/CsA will go off study.


  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: Danielle Townsley MD
Organization: NHLBI, NIH
phone: 301-402-3477
e-mail: townsleydm@nhlbi.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00260689     History of Changes
Other Study ID Numbers: 060034
06-H-0034 ( Other Identifier: NIH )
Study First Received: December 1, 2005
Results First Received: May 16, 2017
Last Updated: May 16, 2017