Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Rabbit Antithymocyte Globulin Versus Campath-1H for Treating Severe Aplastic Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danielle Townsley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00065260
First received: July 18, 2003
Last updated: February 3, 2016
Last verified: February 2016
Results First Received: February 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aplastic Anemia
Interventions: Drug: Campath-1H
Drug: r-ATG
Drug: CsA

  Participant Flow
  Hide 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
r-ATG /Cyclosporine

A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).

r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days

CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs.

Alemtuzumab (Campath-1H)

A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).

Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day).


Participant Flow:   Overall Study
    r-ATG /Cyclosporine     Alemtuzumab (Campath-1H)  
STARTED     27     27  
COMPLETED     27     26  
NOT COMPLETED     0     1  
Death                 0                 1  



  Baseline Characteristics
  Hide 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
r-ATG /Cyclosporine

A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).

r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days

CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs.

Alemtuzumab (Campath-1H)

A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).

Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day).

Total Total of all reporting groups

Baseline Measures
    r-ATG /Cyclosporine     Alemtuzumab (Campath-1H)     Total  
Number of Participants  
[units: participants]
  27     27     54  
Age  
[units: participants]
     
<=18 years     3     9     12  
Between 18 and 65 years     22     14     36  
>=65 years     2     4     6  
Gender  
[units: participants]
     
Female     11     13     24  
Male     16     14     30  
Region of Enrollment  
[units: participants]
     
United States     27     27     54  



  Outcome Measures

1.  Primary:   No Longer Meeting Criteria for Severe Aplastic Anemia.   [ Time Frame: 6 months ]

2.  Secondary:   Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia   [ Time Frame: months/years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Danielle Townsley
Organization: NIH NHLBI
phone: 301-402-3477
e-mail: townsleydm@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Danielle Townsley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00065260     History of Changes
Other Study ID Numbers: 030249
03-H-0249
Study First Received: July 18, 2003
Results First Received: February 3, 2016
Last Updated: February 3, 2016
Health Authority: United States: Food and Drug Administration