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Trial record 7 of 9 for:    "Thrombocytopenia" | "alemtuzumab"

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

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ClinicalTrials.gov Identifier: NCT00065260
Recruitment Status : Completed
First Posted : July 21, 2003
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Danielle Townsley, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aplastic Anemia
Interventions Drug: Campath-1H
Drug: r-ATG
Drug: CsA
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Hide Arm/Group Description

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.

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).

Period Title: Overall Study
Started 27 27
Completed 27 26
Not Completed 0 1
Reason Not Completed
Death             0             1
Arm/Group Title r-ATG /Cyclosporine Alemtuzumab (Campath-1H) Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
<=18 years
3
  11.1%
9
  33.3%
12
  22.2%
Between 18 and 65 years
22
  81.5%
14
  51.9%
36
  66.7%
>=65 years
2
   7.4%
4
  14.8%
6
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
11
  40.7%
13
  48.1%
24
  44.4%
Male
16
  59.3%
14
  51.9%
30
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title No Longer Meeting Criteria for Severe Aplastic Anemia.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 27 26
Measure Type: Number
Unit of Measure: participants
No Response 18 17
Partial Response 9 9
Complete Response 0 0
2.Secondary Outcome
Title Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia
Hide Description [Not Specified]
Time Frame months/years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Hide Arm/Group Description

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.

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).

All-Cause Mortality
r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/27 (25.93%)      12/27 (44.44%)    
Immune system disorders     
infection *  7/27 (25.93%)  7 12/27 (44.44%)  12
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
r-ATG /Cyclosporine Alemtuzumab (Campath-1H)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/27 (25.93%)      12/27 (44.44%)    
Blood and lymphatic system disorders     
infection *  7/27 (25.93%)  7 12/27 (44.44%)  12
*
Indicates events were collected by non-systematic assessment
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: Dr. Danielle Townsley
Organization: NIH NHLBI
Phone: 301-402-3477
EMail: townsleydm@mail.nih.gov
Layout table for additonal information
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
First Submitted: July 18, 2003
First Posted: July 21, 2003
Results First Submitted: February 3, 2016
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016