Trial Outcomes & Findings for Anti-Tac for Treatment of Leukemia (NCT NCT00001941)
NCT ID: NCT00001941
Last Updated: 2012-08-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
21-220 weeks
Results posted on
2012-08-20
Participant Flow
Participant milestones
| Measure |
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 Study
STARTED
|
3
|
5
|
3
|
3
|
20
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
3
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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 Study
not treated- rapidly progressing disease
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Anti-Tac for Treatment of Leukemia
Baseline characteristics by cohort
| Measure |
Phase I & II Cohorts (2-8 mg/kg)
n=34 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
47.37 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21-220 weeksPopulation: Phase I is not reported because phase I studies only determine maximum tolerated dose.
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.
Outcome measures
| Measure |
Phase II- 8 mg/kg Cohort
n=19 Participants
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Duration of Response
|
114 Weeks
Interval 21.0 to 220.0
|
PRIMARY outcome
Timeframe: 132.6 weeksPopulation: Phase I is not reported because phase I studies only determine maximum tolerated dose.
Measured from the time the patient is consented until death.
Outcome measures
| Measure |
Phase II- 8 mg/kg Cohort
n=19 Participants
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Overall Survival
|
132.6 Weeks
Interval 53.9 to
The upper end of the confidence interval was not reached because at last follow-up a patient had an ongoing response at last contact.
|
PRIMARY outcome
Timeframe: up to 220 weeksPopulation: Phase I is not reported because phase I studies only determine maximum tolerated dose.
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
Outcome measures
| Measure |
Phase II- 8 mg/kg Cohort
n=19 Participants
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Percentage of Participants With an Overall Response Rate
|
20 Percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data is not available separately per cohort.
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Phase II- 8 mg/kg Cohort
n=34 Participants
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Number of Participants With Adverse Events
|
32 Participants
|
Adverse Events
Phase II- 8 mg/kg Cohort
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase II- 8 mg/kg Cohort
n=34 participants at risk
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Cardiac disorders
Cardiovascular/Arrhythmia -Other (Specify, congestive heart failure (CHF))
|
2.9%
1/34 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Phase II- 8 mg/kg Cohort
n=34 participants at risk
8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
|
|---|---|
|
Investigations
Amylase
|
11.8%
4/34 • Number of events 25 • 12 months
|
|
Investigations
CPK (creatine phosphokinase)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Investigations
Leukocytes (total white blood count (WBC))
|
11.8%
4/34 • Number of events 24 • 12 months
|
|
Investigations
Lymphopenia
|
8.8%
3/34 • Number of events 13 • 12 months
|
|
Investigations
Neutrophils/granulocytes (absolute neutrophil count (ANC)/absolute granulocyte count (AGC))
|
11.8%
4/34 • Number of events 22 • 12 months
|
|
Investigations
Partial thromboplastin time (PTT)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
General disorders
Edema
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Investigations
Hemoglobin
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Investigations
Hypercholesterolemia
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.8%
4/34 • Number of events 17 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.6%
6/34 • Number of events 13 • 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
2/34 • Number of events 3 • 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify, Lesions Lt elbow)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Investigations
Lipase
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Wound-non-infectious
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
2.9%
1/34 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.9%
2/34 • Number of events 4 • 12 months
|
|
Investigations
Prothrombin time (PT)
|
5.9%
2/34 • Number of events 12 • 12 months
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Infections and infestations
Infection without neutropenia
|
8.8%
3/34 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other (Specify, URI (upper respiratory infection))
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify, UTI (urinary tract infection))
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Investigations
Weight loss
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.9%
1/34 • Number of events 2 • 12 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Nervous system disorders
Neuropathy-sensory
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Investigations
Alkaline phosphatase
|
5.9%
2/34 • Number of events 2 • 12 months
|
|
Hepatobiliary disorders
Bilirubin
|
5.9%
2/34 • Number of events 7 • 12 months
|
|
Investigations
Creatinine
|
5.9%
2/34 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
5.9%
2/34 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
2.9%
1/34 • Number of events 2 • 12 months
|
|
Ear and labyrinth disorders
Earache (otalgia)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Endocrine disorders
Hypothyroidism
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
2/34 • Number of events 3 • 12 months
|
|
Investigations
SGOT (aspartate aminotransferase (AST)) (serum glutamic oxaloacetic transaminase)
|
17.6%
6/34 • Number of events 8 • 12 months
|
|
Investigations
SGPT (alanine aminotransferase (ALT)) (serum glutamic pyruvic transaminase)
|
14.7%
5/34 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Platelets
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
17.6%
6/34 • Number of events 8 • 12 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/34 • Number of events 1 • 12 months
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
2.9%
1/34 • Number of events 2 • 12 months
|
|
General disorders
Pain-Other (Specify, sore throat pain ; rt knee pain)
|
5.9%
2/34 • Number of events 2 • 12 months
|
Additional Information
Thomas Waldmann, M.D.
National Cancer Institute, National Institues of Health
Phone: 301-496-6653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place