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A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure

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ClinicalTrials.gov Identifier: NCT00001962
Recruitment Status : Terminated (DSMB recommended closing the study and publishing the results)
First Posted : January 19, 2000
Results First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Neal Young, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Aplastic Anemia
Pure Red Cell Aplasia
Diamond Blackfan Anemia
Intervention: Drug: Daclizumab

  Participant Flow

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
Daclizumab Hematologic Response daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.The Diamond Blackfan anemia arm was closed due to lack of accrual.

Participant Flow:   Overall Study
    Daclizumab Hematologic Response
STARTED   100 
COMPLETED   72 
NOT COMPLETED   28 
Lack of Efficacy                18 
Lack of Accrual                6 
Death                1 
Lost to Follow-up                2 
Adverse Event                1 



  Baseline Characteristics

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
Daclizumab Hematologic Response daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.

Baseline Measures
   Daclizumab Hematologic Response 
Overall Participants Analyzed 
[Units: Participants]
 100 
Age 
[Units: Participants]
 
<=18 years   27 
Between 18 and 65 years   57 
>=65 years   16 
Gender 
[Units: Participants]
 
Female   49 
Male   51 


  Outcome Measures

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

2.  Secondary:   Change in the Transfusion Requirements, Overall Survival.   [ Time Frame: 3 and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Neal Young MD
Organization: NIH National Heart, Lung and Blood Institute
phone: 301-496-5093
e-mail: youngns@nhlbi.nih.gov


Publications:

Responsible Party: Neal Young, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00001962     History of Changes
Other Study ID Numbers: 000029
00-H-0029 ( Other Identifier: NIH NHLBI )
First Submitted: January 18, 2000
First Posted: January 19, 2000
Results First Submitted: April 20, 2011
Results First Posted: May 14, 2015
Last Update Posted: May 14, 2015