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Trial record 6 of 9 for:    "Thrombocytopenia" | "alemtuzumab"

Alemtuzumab to Treat Severe Aplastic Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195624
Recruitment Status : Active, not recruiting
First Posted : September 19, 2005
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Severe Aplastic Anemia, Refractory
Severe Aplastic Anemia, Relapse
Interventions Biological: Alemtuzumab (Campath )
Drug: Cyclosporine
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Refractory Relapsed
Hide Arm/Group Description Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy. Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
Period Title: Overall Study
Started 5 42
Completed 5 42
Not Completed 0 0
Arm/Group Title Refractory Relapsed Total
Hide Arm/Group Description Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy. Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy. Total of all reporting groups
Overall Number of Baseline Participants 5 42 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 42 participants 47 participants
<=18 years
1
  20.0%
6
  14.3%
7
  14.9%
Between 18 and 65 years
3
  60.0%
27
  64.3%
30
  63.8%
>=65 years
1
  20.0%
9
  21.4%
10
  21.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 42 participants 47 participants
Female
1
  20.0%
24
  57.1%
25
  53.2%
Male
4
  80.0%
18
  42.9%
22
  46.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 42 participants 47 participants
Hispanic or Latino
2
  40.0%
6
  14.3%
8
  17.0%
Not Hispanic or Latino
3
  60.0%
35
  83.3%
38
  80.9%
Unknown or Not Reported
0
   0.0%
1
   2.4%
1
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 42 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  20.0%
2
   4.8%
3
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
10
  23.8%
10
  21.3%
White
2
  40.0%
23
  54.8%
25
  53.2%
More than one race
0
   0.0%
3
   7.1%
3
   6.4%
Unknown or Not Reported
2
  40.0%
4
   9.5%
6
  12.8%
1.Primary Outcome
Title Hematological Response Rate at 6 Months
Hide Description Hematological response is defined as no longer satisfying blood count criteria for Severe Aplastic Anemia. Patients were classified as responders if they met two of the following three criteria: ANC greater than 500/ mm'; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3 (60,000/mm3 after January 1993).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory Relapsed
Hide Arm/Group Description:
Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy.
Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
Overall Number of Participants Analyzed 5 42
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
18
  42.9%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Refractory Relapsed
Hide Arm/Group Description Patients who are refractory to prior courses of horse and rabbit antithymocyte globulin (ATG) based immunosuppresive therapy. Patients who have responded and relapsed following a prior course of antithymocyte globulin (ATG) based immunosuppresive therapy.
All-Cause Mortality
Refractory Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   13/42 (30.95%) 
Show Serious Adverse Events Hide Serious Adverse Events
Refractory Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   22/42 (52.38%) 
Blood and lymphatic system disorders     
Anaemia   0/5 (0.00%)  2/42 (4.76%) 
Febrile neutropenia   1/5 (20.00%)  15/42 (35.71%) 
Cardiac disorders     
Cardiac failure   1/5 (20.00%)  0/42 (0.00%) 
Presyncope   0/5 (0.00%)  1/42 (2.38%) 
Gastrointestinal disorders     
Gastritis   0/5 (0.00%)  1/42 (2.38%) 
Gastrointestinal haemorrhage   0/5 (0.00%)  1/42 (2.38%) 
Immune system disorders     
Allergic transfusion reaction   0/5 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Fungal infection   0/5 (0.00%)  1/42 (2.38%) 
Pneumonia   0/5 (0.00%)  1/42 (2.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Haemorrhagic ovarian cyst   0/5 (0.00%)  1/42 (2.38%) 
Nervous system disorders     
Central nervous system inflammation   0/5 (0.00%)  1/42 (2.38%) 
Cerebral ischaemia   0/5 (0.00%)  1/42 (2.38%) 
Reproductive system and breast disorders     
Vaginal ulceration   0/5 (0.00%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis   0/5 (0.00%)  1/42 (2.38%) 
Skin and subcutaneous tissue disorders     
Rash   0/5 (0.00%)  1/42 (2.38%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Refractory Relapsed
Affected / at Risk (%) Affected / at Risk (%)
Total   4/5 (80.00%)   42/42 (100.00%) 
Blood and lymphatic system disorders     
Ecchymosis   0/5 (0.00%)  6/42 (14.29%) 
Febrile neutropenia   0/5 (0.00%)  1/42 (2.38%) 
Haemolysis   0/5 (0.00%)  1/42 (2.38%) 
Lymphopenia   0/5 (0.00%)  14/42 (33.33%) 
Neutropenia   0/5 (0.00%)  1/42 (2.38%) 
Petechiae   1/5 (20.00%)  7/42 (16.67%) 
Thrombocytopenia   1/5 (20.00%)  0/42 (0.00%) 
Transfusion reaction   0/5 (0.00%)  1/42 (2.38%) 
Cardiac disorders     
Arrhythmia   0/5 (0.00%)  1/42 (2.38%) 
Chest discomfort   0/5 (0.00%)  3/42 (7.14%) 
Chest pain   0/5 (0.00%)  3/42 (7.14%) 
Dizziness   0/5 (0.00%)  6/42 (14.29%) 
Dyspnoea   0/5 (0.00%)  6/42 (14.29%) 
Dyspnoea exertional   0/5 (0.00%)  2/42 (4.76%) 
Palpitations   0/5 (0.00%)  2/42 (4.76%) 
Tachycardia   0/5 (0.00%)  2/42 (4.76%) 
Ear and labyrinth disorders     
Hypoacusis   0/5 (0.00%)  1/42 (2.38%) 
Endocrine disorders     
Hyperglycaemia   0/5 (0.00%)  1/42 (2.38%) 
Hypothyroidism   1/5 (20.00%)  0/42 (0.00%) 
Eye disorders     
Conjunctival haemorrhage   0/5 (0.00%)  1/42 (2.38%) 
Conjunctivitis   0/5 (0.00%)  1/42 (2.38%) 
Dry eye   0/5 (0.00%)  1/42 (2.38%) 
Eye irritation   0/5 (0.00%)  1/42 (2.38%) 
Eye pain   0/5 (0.00%)  2/42 (4.76%) 
Eye swelling   0/5 (0.00%)  1/42 (2.38%) 
Scleral haemorrhage   0/5 (0.00%)  1/42 (2.38%) 
Vision blurred   0/5 (0.00%)  2/42 (4.76%) 
Visual impairment   0/5 (0.00%)  2/42 (4.76%) 
Gastrointestinal disorders     
Abdominal pain   0/5 (0.00%)  6/42 (14.29%) 
Abnormal faeces   0/5 (0.00%)  1/42 (2.38%) 
Constipation   1/5 (20.00%)  1/42 (2.38%) 
Diarrhoea   1/5 (20.00%)  3/42 (7.14%) 
Dry mouth   0/5 (0.00%)  2/42 (4.76%) 
Dyspepsia   1/5 (20.00%)  2/42 (4.76%) 
Gastrooesophageal reflux disease   0/5 (0.00%)  1/42 (2.38%) 
Gingival bleeding   0/5 (0.00%)  5/42 (11.90%) 
Mouth ulceration   0/5 (0.00%)  1/42 (2.38%) 
Nausea   0/5 (0.00%)  8/42 (19.05%) 
Oral mucosal blistering   0/5 (0.00%)  1/42 (2.38%) 
Oropharyngeal pain   0/5 (0.00%)  2/42 (4.76%) 
Rectal haemorrhage   0/5 (0.00%)  1/42 (2.38%) 
Stomatitis   1/5 (20.00%)  2/42 (4.76%) 
Vomiting   0/5 (0.00%)  4/42 (9.52%) 
General disorders     
Asthenia   0/5 (0.00%)  2/42 (4.76%) 
Catheter site pain   0/5 (0.00%)  1/42 (2.38%) 
Chills   0/5 (0.00%)  15/42 (35.71%) 
Cold sweat   0/5 (0.00%)  1/42 (2.38%) 
Decreased appetite   1/5 (20.00%)  2/42 (4.76%) 
Discomfort   0/5 (0.00%)  1/42 (2.38%) 
Fatigue   0/5 (0.00%)  12/42 (28.57%) 
Feeling cold   0/5 (0.00%)  2/42 (4.76%) 
Flushing   0/5 (0.00%)  1/42 (2.38%) 
Hot flush   0/5 (0.00%)  1/42 (2.38%) 
Hyperhidrosis   0/5 (0.00%)  1/42 (2.38%) 
Infusion related reaction   4/5 (80.00%)  25/42 (59.52%) 
Injection site inflammation   0/5 (0.00%)  2/42 (4.76%) 
Night sweats   0/5 (0.00%)  2/42 (4.76%) 
Pain   0/5 (0.00%)  7/42 (16.67%) 
Pallor   0/5 (0.00%)  1/42 (2.38%) 
Peripheral coldness   0/5 (0.00%)  1/42 (2.38%) 
Pyrexia   0/5 (0.00%)  16/42 (38.10%) 
Immune system disorders     
Allergic sinusitis   0/5 (0.00%)  1/42 (2.38%) 
Bronchospasm   0/5 (0.00%)  1/42 (2.38%) 
Urticaria   0/5 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Bacteraemia   0/5 (0.00%)  1/42 (2.38%) 
Herpes simplex   0/5 (0.00%)  1/42 (2.38%) 
Herpes zoster   0/5 (0.00%)  1/42 (2.38%) 
Pharyngitis streptococcal   0/5 (0.00%)  1/42 (2.38%) 
Upper respiratory tract infection   2/5 (40.00%)  6/42 (14.29%) 
Urinary tract infection   0/5 (0.00%)  2/42 (4.76%) 
Viral upper respiratory tract infection   0/5 (0.00%)  1/42 (2.38%) 
Vulvovaginal candidiasis   0/5 (0.00%)  1/42 (2.38%) 
Injury, poisoning and procedural complications     
Contusion   0/5 (0.00%)  11/42 (26.19%) 
Iron overload   0/5 (0.00%)  5/42 (11.90%) 
Investigations     
Alanine aminotransferase increased   0/5 (0.00%)  2/42 (4.76%) 
Aspartate aminotransferase increased   0/5 (0.00%)  2/42 (4.76%) 
Blood bilirubin increased   0/5 (0.00%)  1/42 (2.38%) 
Blood calcium decreased   0/5 (0.00%)  1/42 (2.38%) 
Blood lactate dehydrogenase increased   0/5 (0.00%)  1/42 (2.38%) 
Blood magnesium decreased   0/5 (0.00%)  2/42 (4.76%) 
Blood pressure decreased   0/5 (0.00%)  3/42 (7.14%) 
Blood urine present   0/5 (0.00%)  1/42 (2.38%) 
Cardiac murmur   0/5 (0.00%)  1/42 (2.38%) 
Heart rate increased   0/5 (0.00%)  1/42 (2.38%) 
Liver function test increased   0/5 (0.00%)  6/42 (14.29%) 
Lymphocyte count decreased   0/5 (0.00%)  1/42 (2.38%) 
Oxygen saturation decreased   0/5 (0.00%)  1/42 (2.38%) 
Respiratory rate increased   0/5 (0.00%)  1/42 (2.38%) 
Transaminases   0/5 (0.00%)  2/42 (4.76%) 
Transaminases increased   0/5 (0.00%)  1/42 (2.38%) 
Weight decreased   0/5 (0.00%)  1/42 (2.38%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   0/5 (0.00%)  1/42 (2.38%) 
Back pain   0/5 (0.00%)  3/42 (7.14%) 
Muscle atrophy   1/5 (20.00%)  0/42 (0.00%) 
Muscle spasms   0/5 (0.00%)  1/42 (2.38%) 
Musculoskeletal chest pain   0/5 (0.00%)  1/42 (2.38%) 
Myalgia   0/5 (0.00%)  1/42 (2.38%) 
Pain in extremity   0/5 (0.00%)  1/42 (2.38%) 
Pain in jaw   0/5 (0.00%)  1/42 (2.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Dermal cyst   1/5 (20.00%)  0/42 (0.00%) 
Nervous system disorders     
Headache   0/5 (0.00%)  10/42 (23.81%) 
Insomnia   0/5 (0.00%)  3/42 (7.14%) 
Somnolence   0/5 (0.00%)  1/42 (2.38%) 
Psychiatric disorders     
Anxiety   0/5 (0.00%)  2/42 (4.76%) 
Depressed mood   0/5 (0.00%)  1/42 (2.38%) 
Depression   0/5 (0.00%)  1/42 (2.38%) 
Mood altered   0/5 (0.00%)  1/42 (2.38%) 
Sleep disorder   0/5 (0.00%)  1/42 (2.38%) 
Renal and urinary disorders     
Haematuria   0/5 (0.00%)  1/42 (2.38%) 
Reproductive system and breast disorders     
Menstrual disorder   0/5 (0.00%)  1/42 (2.38%) 
Vaginal haemorrhage   0/5 (0.00%)  3/42 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough   0/5 (0.00%)  10/42 (23.81%) 
Epistaxis   0/5 (0.00%)  3/42 (7.14%) 
Increased viscosity of upper respiratory secretion   0/5 (0.00%)  2/42 (4.76%) 
Nasal congestion   0/5 (0.00%)  1/42 (2.38%) 
Respiratory tract congestion   0/5 (0.00%)  1/42 (2.38%) 
Rhinorrhoea   0/5 (0.00%)  1/42 (2.38%) 
Upper-airway cough syndrome   0/5 (0.00%)  1/42 (2.38%) 
Wheezing   0/5 (0.00%)  1/42 (2.38%) 
Skin and subcutaneous tissue disorders     
Alopecia   0/5 (0.00%)  1/42 (2.38%) 
Dry skin   0/5 (0.00%)  2/42 (4.76%) 
Eczema   0/5 (0.00%)  1/42 (2.38%) 
Pityriasis rosea   0/5 (0.00%)  1/42 (2.38%) 
Pruritus   0/5 (0.00%)  3/42 (7.14%) 
Pruritus generalised   0/5 (0.00%)  1/42 (2.38%) 
Rash   0/5 (0.00%)  10/42 (23.81%) 
Rash generalised   0/5 (0.00%)  1/42 (2.38%) 
Rash macular   0/5 (0.00%)  1/42 (2.38%) 
Rash maculo-papular   0/5 (0.00%)  1/42 (2.38%) 
Rash papular   0/5 (0.00%)  1/42 (2.38%) 
Rash pruritic   0/5 (0.00%)  8/42 (19.05%) 
Skin Infiltration   0/5 (0.00%)  1/42 (2.38%) 
Skin irritation   0/5 (0.00%)  1/42 (2.38%) 
Vascular disorders     
Aortic dilatation   0/5 (0.00%)  1/42 (2.38%) 
Blood pressure inadequately controlled   0/5 (0.00%)  1/42 (2.38%) 
Haemorrhage   0/5 (0.00%)  2/42 (4.76%) 
Hypertension   0/5 (0.00%)  1/42 (2.38%) 
Indicates events were collected by 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: Young, Neal
Organization: National Heart Lung and Blood Institute
Phone: +1 301 496 5093
EMail: youngns@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00195624     History of Changes
Other Study ID Numbers: 050242
05-H-0242
First Submitted: September 16, 2005
First Posted: September 19, 2005
Results First Submitted: July 11, 2019
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019