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Trial record 17 of 44 for:    Malignant Hyperthermia 5

A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00217594
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 24, 2018
Last Update Posted : October 30, 2018
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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myelodysplastic Syndromes
Intervention Drug: Alemtuzumab (Campath)
Enrollment 40
Recruitment Details  
Pre-assignment Details Out of 40 enrolled subjects, only 31 subjects were evaluable.
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
57
(23 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
9
  29.0%
Male
22
  71.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 31 participants
White
24
  77.4%
African American
2
   6.5%
Asian
2
   6.5%
Hispanic
3
   9.7%
1.Primary Outcome
Title Response to Treatment - Hematologic Improvement or Complete Response
Hide Description

Response to treatment at 3 months after the first dose of alemtuzumab. The parameters for hematologic improvement (HI) and complete response (CR) were defined according to the International Working Group (IWG) criteria. The IWG criteria for HI define specific responses of cytopenias in the 3 hematopoietic lineages: erythroid (HI-E), platelet (HI-P), and neutrophil (HI-N).7 The HIs are measured in patients with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or RBC-transfusion dependence, platelet count less than 100 × 109/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 × 109/L.

The parameters for CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more (in patients not receiving erythropoietin or transfusions), a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alemtuzumab
Hide Arm/Group Description:
Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
21
  67.7%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alemtuzumab
Hide Arm/Group Description Patients received a 1-mg test dose of alemtuzumab, and the following day, alemtuzumab was administered at 10 mg/dose intravenously for 10 days
All-Cause Mortality
Alemtuzumab
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Alemtuzumab
Affected / at Risk (%)
Total   15/31 (48.39%) 
Blood and lymphatic system disorders   
Autoimmune thrombocytopenia   1/31 (3.23%) 
Infections and infestations   
Bacterial pneumonia   1/31 (3.23%) 
Cellulitis   1/31 (3.23%) 
Clostridium difficile diarrhea   2/31 (6.45%) 
Neutropenic fever   3/31 (9.68%) 
Non-neutropenic fever   2/31 (6.45%) 
Shingles   1/31 (3.23%) 
Sinusitis   1/31 (3.23%) 
URI symptoms   1/31 (3.23%) 
Injury, poisoning and procedural complications   
Hypotension   1/31 (3.23%) 
Skin and subcutaneous tissue disorders   
Molluscum contagiosum skin lesion   1/31 (3.23%) 
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%
Alemtuzumab
Affected / at Risk (%)
Total   31/31 (100.00%) 
Blood and lymphatic system disorders   
Hand swelling   1/31 (3.23%) 
Cardiac disorders   
Hypertension   1/31 (3.23%) 
Gastrointestinal disorders   
Diarrhea   1/31 (3.23%) 
Nausea   1/31 (3.23%) 
General disorders   
Asthenia   2/31 (6.45%) 
Fatigue   1/31 (3.23%) 
Stiffness   1/31 (3.23%) 
Headache   2/31 (6.45%) 
Infections and infestations   
Orchitis   1/31 (3.23%) 
Pilonidal cyst   1/31 (3.23%) 
Upper respiratory tract   9/31 (29.03%) 
Mycobacterium chelonae   1/31 (3.23%) 
Injury, poisoning and procedural complications   
Infusion reaction   23/31 (74.19%) 
Metabolism and nutrition disorders   
Decreased phosphate   1/31 (3.23%) 
Elevated AST, ALT   8/31 (25.81%) 
Elevated LDH   1/31 (3.23%) 
Elevated creatinine   1/31 (3.23%) 
Musculoskeletal and connective tissue disorders   
Muscle cramps   3/31 (9.68%) 
Nervous system disorders   
Dizziness   1/31 (3.23%) 
Neuropathic   1/31 (3.23%) 
Renal and urinary disorders   
Darkened urine   1/31 (3.23%) 
Skin and subcutaneous tissue disorders   
Facial flushing   1/31 (3.23%) 
Pruritus   1/31 (3.23%) 
Rash   2/31 (6.45%) 
Urticaria   3/31 (9.68%) 
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: Chris Hourigan MD
Organization: NHLBI, NIH
Phone: 301-451-0257
EMail: hourigancs@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: NCT00217594     History of Changes
Obsolete Identifiers: NCT00123721
Other Study ID Numbers: 050206
05-H-0206
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: August 23, 2018
Results First Posted: September 24, 2018
Last Update Posted: October 30, 2018