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Anti-Tac for Treatment of Leukemia

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ClinicalTrials.gov Identifier: NCT00001941
Recruitment Status : Completed
First Posted : January 19, 2000
Results First Posted : August 9, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HTLV-I Infection
T Cell Leukemia
Intervention Biological: daclizumab
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I - 2 mg/kg Cohort Phase I - 4 mg/kg Cohort Phase I - 6 mg/kg Cohort Phase I - 8 mg/kg Cohort Phase II- 8 mg/kg Cohort
Hide Arm/Group Description 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Period Title: Overall Study
Started 3 5 3 3 20
Completed 3 5 3 3 19
Not Completed 0 0 0 0 1
Reason Not Completed
not treated- rapidly progressing disease             0             0             0             0             1
Arm/Group Title Phase I & II Cohorts (2-8 mg/kg)
Hide Arm/Group Description Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
1
   2.9%
Between 18 and 65 years
29
  85.3%
>=65 years
4
  11.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
47.37  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
17
  50.0%
Male
17
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Hispanic or Latino
2
   5.9%
Not Hispanic or Latino
32
  94.1%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Black 25
Hispanic 2
White 6
Asian 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a >=25% increase in leukemic cell count.
Time Frame 21-220 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I is not reported because phase I studies only determine maximum tolerated dose.
Arm/Group Title Phase II- 8 mg/kg Cohort
Hide Arm/Group Description:
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: Weeks
114
(21 to 220)
2.Primary Outcome
Title Overall Survival
Hide Description Measured from the time the patient is consented until death.
Time Frame 132.6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I is not reported because phase I studies only determine maximum tolerated dose.
Arm/Group Title Phase II- 8 mg/kg Cohort
Hide Arm/Group Description:
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Overall Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Weeks
132.6 [1] 
(53.9 to NA)
[1]
The upper end of the confidence interval was not reached because at last follow-up a patient had an ongoing response at last contact.
3.Primary Outcome
Title Percentage of Participants With an Overall Response Rate
Hide Description Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a >=25% increase in leukemic cell count
Time Frame up to 220 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I is not reported because phase I studies only determine maximum tolerated dose.
Arm/Group Title Phase II- 8 mg/kg Cohort
Hide Arm/Group Description:
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Percentage of participants
20
4.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data is not available separately per cohort.
Arm/Group Title Phase I & II Cohorts (2-8 mg/kg)
Hide Arm/Group Description:
Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
32
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase II- 8 mg/kg Cohort
Hide Arm/Group Description 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
All-Cause Mortality
Phase II- 8 mg/kg Cohort
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase II- 8 mg/kg Cohort
Affected / at Risk (%) # Events
Total   1/34 (2.94%)    
Cardiac disorders   
Cardiovascular/Arrhythmia -Other (Specify, congestive heart failure (CHF))  1  1/34 (2.94%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase II- 8 mg/kg Cohort
Affected / at Risk (%) # Events
Total   32/34 (94.12%)    
Blood and lymphatic system disorders   
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia  1  1/34 (2.94%)  1
Platelets  1  1/34 (2.94%)  1
Ear and labyrinth disorders   
Earache (otalgia)  1  1/34 (2.94%)  1
Endocrine disorders   
Hypothyroidism  1  1/34 (2.94%)  1
Gastrointestinal disorders   
Flatulence  1  1/34 (2.94%)  1
Diarrhea patients without colostomy  1  2/34 (5.88%)  3
Dyspepsia/heartburn  1  1/34 (2.94%)  1
Nausea  1  1/34 (2.94%)  1
Vomiting  1  1/34 (2.94%)  1
General disorders   
Edema  1 [1]  1/34 (2.94%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/34 (2.94%)  1
Fatigue (lethargy, malaise, asthenia)  1  1/34 (2.94%)  1
Pain-Other (Specify, sore throat pain ; rt knee pain)  1  2/34 (5.88%)  2
Hepatobiliary disorders   
Bilirubin  1  2/34 (5.88%)  7
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  1  1/34 (2.94%)  1
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/34 (2.94%)  2
Infections and infestations   
Infection without neutropenia  1  3/34 (8.82%)  3
Injury, poisoning and procedural complications   
Wound-non-infectious  1  1/34 (2.94%)  1
Investigations   
Amylase  1  4/34 (11.76%)  25
CPK (creatine phosphokinase)  1  1/34 (2.94%)  1
Leukocytes (total white blood count (WBC))  1  4/34 (11.76%)  24
Lymphopenia  1  3/34 (8.82%)  13
Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))  1  4/34 (11.76%)  22
Partial thromboplastin time (PTT)  1  1/34 (2.94%)  1
Hemoglobin  1  2/34 (5.88%)  2
Hypercholesterolemia  1  2/34 (5.88%)  2
Lipase  1  2/34 (5.88%)  2
Prothrombin time (PT)  1  2/34 (5.88%)  12
Weight loss  1  1/34 (2.94%)  1
Alkaline phosphatase  1  2/34 (5.88%)  2
Creatinine  1  2/34 (5.88%)  3
SGOT (aspartate aminotransferase (AST)) (serum glutamic oxaloacetic transaminase)  1  6/34 (17.65%)  8
SGPT (alanine aminotransferase (ALT)) (serum glutamic pyruvic transaminase)  1  5/34 (14.71%)  7
Metabolism and nutrition disorders   
Hypercalcemia  1  2/34 (5.88%)  2
Hyperglycemia  1  4/34 (11.76%)  17
Hyperkalemia  1  2/34 (5.88%)  2
Hypertriglyceridemia  1  2/34 (5.88%)  2
Hypoalbuminemia  1  6/34 (17.65%)  13
Hypomagnesemia  1  2/34 (5.88%)  3
Hyperuricemia  1  6/34 (17.65%)  8
Hyponatremia  1  1/34 (2.94%)  1
Musculoskeletal and connective tissue disorders   
Myalgia (muscle pain)  1  2/34 (5.88%)  2
Arthralgia (joint pain)  1  1/34 (2.94%)  2
Nervous system disorders   
Headache  1  1/34 (2.94%)  1
Neuropathy-sensory  1  1/34 (2.94%)  1
Psychiatric disorders   
Insomnia  1  1/34 (2.94%)  1
Renal and urinary disorders   
Renal/Genitourinary-Other (Specify, UTI (urinary tract infection))  1  1/34 (2.94%)  1
Dysuria (painful urination)  1  1/34 (2.94%)  2
Proteinuria  1  2/34 (5.88%)  3
Respiratory, thoracic and mediastinal disorders   
Pulmonary-Other (Specify, URI (upper respiratory infection))  1  1/34 (2.94%)  1
Cough  1  1/34 (2.94%)  1
Dyspnea (shortness of breath)  1  1/34 (2.94%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other (Specify, Lesions Lt elbow)  1  1/34 (2.94%)  1
Rash/desquamation  1  2/34 (5.88%)  4
Photosensitivity  1  1/34 (2.94%)  2
Sweating (diaphoresis)  1  1/34 (2.94%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
[1]
feet edema mild edema in lower extremities edema legs
Study was closed to accrual since the cessation of the production of daclizumab.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Thomas Waldmann, M.D.
Organization: National Cancer Institute, National Institues of Health
Phone: 301-496-6653
Responsible Party: Thomas A. Waldmann, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00001941     History of Changes
Obsolete Identifiers: NCT00020020
Other Study ID Numbers: 000030
00-C-0030
First Submitted: January 18, 2000
First Posted: January 19, 2000
Results First Submitted: April 23, 2012
Results First Posted: August 9, 2012
Last Update Posted: August 20, 2012