Trial · NCT00363779
Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
NCT00363779, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia. Trials, record NCT00363779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
- NCT number
- NCT00363779
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Large Granular Lymphocytic Leukemia, LGL Leukemia
- Interventions
- Cyclosporine, Gene expression analysis, Microarray analysis, Laboratory biomarker analysis
- First posted
- 2006-08-15
- Last updated
- 2015-07-21
- Results first posted
- 2012-07-06
- Limitations and caveats
As there were only 5 patients treated, the primary endpoints of this protocol were not met and there is not enough data generated for statistical analysis. This protocol is being terminated due to low accrual and the investigator leaving the NIH.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Gene Expression Patterns | Baseline and 12 weeks | 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. |
| Secondary | Number of Participants With Adverse Events | 3 months | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Gene Expression Patterns | Baseline and 12 weeks | This outcome measure was not performed because there were insufficient data points to provide any statistical power. | ||
| SECONDARY | Number of Participants With Adverse Events | 3 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | LGL Patients Administered Cyclosporine | 5 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LGL Patients Administered Cyclosporine | 5 | |
| Overall Study | COMPLETED | LGL Patients Administered Cyclosporine | 5 | |
| Overall Study | NOT COMPLETED | LGL Patients Administered Cyclosporine | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | LGL Patients Administered Cyclosporine | 2 | 5 | 2 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | LGL Patients Administered Cyclosporine | 1 | 5 | 1 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | LGL Patients Administered Cyclosporine | 4 | 5 | 7 |
| other | Alkaline phosphatase | Investigations | LGL Patients Administered Cyclosporine | 2 | 5 | 3 |
| other | Bicarbonate, serum-low | Investigations | LGL Patients Administered Cyclosporine | 1 | 5 | 1 |
| other | Bilirubin (hyperbilirubinemia) | Investigations | LGL Patients Administered Cyclosporine | 5 | 5 | 10 |
| other | Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | LGL Patients Administered Cyclosporine | 1 | 5 | 2 |
| other | Cholesterol, serum-high (hypercholesteremia) | Investigations | LGL Patients Administered Cyclosporine | 1 | 5 | 2 |
| other | Creatinine | Investigations | LGL Patients Administered Cyclosporine | 1 | 5 | 2 |
| other | Dizziness | Nervous system disorders | LGL Patients Administered Cyclosporine | 2 | 5 | 2 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LGL Patients Administered Cyclosporine | ||
| Total, other adverse events | LGL Patients Administered Cyclosporine | 5 | 5 |
| Total, serious adverse events | LGL Patients Administered Cyclosporine | 2 | 5 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00363779
GET https://conductscience.org/api/trials/v1/NCT00363779/events?page=2