Trial Outcomes & Findings for Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia (NCT NCT00363779)
NCT ID: NCT00363779
Last Updated: 2015-07-21
Results Overview
The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2015-07-21
Participant Flow
Participant milestones
| Measure |
LGL Patients Administered Cyclosporine
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
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|---|---|
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Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
Baseline characteristics by cohort
| Measure |
LGL Patients Administered Cyclosporine
n=5 Participants
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 6.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: This outcome measure was not performed because there were insufficient data points to provide any statistical power.
The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsHere are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
LGL Patients Administered Cyclosporine
n=5 Participants
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
|
|---|---|
|
Number of Participants With Adverse Events
|
5 Participants
|
Adverse Events
LGL Patients Administered Cyclosporine
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LGL Patients Administered Cyclosporine
n=5 participants at risk
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
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|---|---|
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Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-Lung (pneumonia)
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second malignancy-possibly related to cancer treatment (Specify) new abdominal mass
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
Other adverse events
| Measure |
LGL Patients Administered Cyclosporine
n=5 participants at risk
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
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|---|---|
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Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
40.0%
2/5 • Number of events 2 • 3 yrs, 10 months
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
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20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
80.0%
4/5 • Number of events 7 • 3 yrs, 10 months
|
|
Investigations
Alkaline phosphatase
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40.0%
2/5 • Number of events 3 • 3 yrs, 10 months
|
|
Investigations
Bicarbonate, serum-low
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
100.0%
5/5 • Number of events 10 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
20.0%
1/5 • Number of events 2 • 3 yrs, 10 months
|
|
Investigations
Cholesterol, serum-high (hypercholesteremia)
|
20.0%
1/5 • Number of events 2 • 3 yrs, 10 months
|
|
Investigations
Creatinine
|
20.0%
1/5 • Number of events 2 • 3 yrs, 10 months
|
|
Nervous system disorders
Dizziness
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40.0%
2/5 • Number of events 2 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
60.0%
3/5 • Number of events 8 • 3 yrs, 10 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.0%
3/5 • Number of events 11 • 3 yrs, 10 months
|
|
Vascular disorders
Hypertension
|
60.0%
3/5 • Number of events 3 • 3 yrs, 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Investigations
Leukocytes (total WBC)
|
40.0%
2/5 • Number of events 2 • 3 yrs, 10 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
1/5 • Number of events 5 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
100.0%
5/5 • Number of events 6 • 3 yrs, 10 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
20.0%
1/5 • Number of events 2 • 3 yrs, 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Nervous system disorders
Pain::Head/headache
|
80.0%
4/5 • Number of events 5 • 3 yrs, 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain::Muscle
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Investigations
Platelets
|
60.0%
3/5 • Number of events 6 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
40.0%
2/5 • Number of events 2 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
80.0%
4/5 • Number of events 9 • 3 yrs, 10 months
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
20.0%
1/5 • Number of events 2 • 3 yrs, 10 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
20.0%
1/5 • Number of events 1 • 3 yrs, 10 months
|
Additional Information
Thomas Waldmann, M.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-6653
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place