Trial · NCT03601806
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
NCT03601806, Phase 2, Completed, AIDS Malignancy Consortium; results first posted 2026-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection. Trials, record NCT03601806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03601806
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
- NCT number
- NCT03601806
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- Human Immunodeficiency Virus 1 Positive, Skin Kaposi Sarcoma
- Interventions
- Laboratory Biomarker Analysis, Pomalidomide
- First posted
- 2018-07-26
- Last updated
- 2026-04-13
- Results first posted
- 2026-02-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Up to 48 weeks | The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate. |
| Primary | Complete Response Rate | Up to 48 weeks | The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate |
| Primary | Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Up to 1 year | Incidence of Grade 3 or higher toxicity will be reported using percentage and corresponding 95% confidence interval. The binomial proportion and its 95% exact confidence interval will be used to estimate the proportion of participants who experience a grade 3 or higher toxicity. |
| Secondary | Changes in CD4 T Cell Count | Baseline to up to 1 year | Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated. |
| Secondary | Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction | Baseline to up to 1 year | Changes in CD4 counts and HIV viral load will be evaluated. |
| Other | Changes in Serum Cytokine Levels as Measured by Luminex Assay | Baseline to up to 48 weeks | General estimating equations will be used to evaluate changes in cytokine levels over time. Logistic regression analyses will be used to evaluate the association between cytokine levels and clinical response. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Up to 48 weeks | Study participants who received study treatment | proportion of participants | NUMBER |
| PRIMARY | Complete Response Rate | Up to 48 weeks | Study participants who received study treatment | proportion of participants | NUMBER |
| PRIMARY | Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Up to 1 year | Study participants who received study treatment | percentage of participants | NUMBER |
| SECONDARY | Changes in CD4 T Cell Count | Baseline to up to 1 year | Participants with CD4 measurement at baseline and 1 year | CD4 T cell counts per mm^3 | MEAN |
| SECONDARY | Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction | Baseline to up to 1 year | Participants with HIV viral load measurement at baseline and 1 year | HIV viral load copies per mL | MEAN |
| OTHER_PRE_SPECIFIED | Changes in Serum Cytokine Levels as Measured by Luminex Assay | Baseline to up to 48 weeks |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Treatment (Pomalidomide) | 0.577 | 95% Confidence Interval 0.369 to 0.766 | proportion of participants | |
| Complete Response Rate | Treatment (Pomalidomide) | 0 | 95% Confidence Interval 0 to 0.16 | proportion of participants | |
| Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Pomalidomide) | All adverse events | 57.7 | 95% Confidence Interval 37.2 to 76 | percentage of participants |
| Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Pomalidomide) | Treatment-related adverse events | 38.5 | 95% Confidence Interval 20.9 to 59.3 | percentage of participants |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Baseline | 456 | Standard Deviation 247.5 | CD4 T cell counts per mm^3 |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Cycle 2 Day 1 | 524.1 | Standard Deviation 194.2 | CD4 T cell counts per mm^3 |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Cycle4 Day 1 | 512.6 | Standard Deviation 251.5 | CD4 T cell counts per mm^3 |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Cycle 7 Day 1 | 587.8 | Standard Deviation 327.3 | CD4 T cell counts per mm^3 |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Cycle 10 Day 1 | 417.4 | Standard Deviation 203 | CD4 T cell counts per mm^3 |
| Changes in CD4 T Cell Count | Treatment (Pomalidomide) | Treatment Discontinuation | 484.6 | Standard Deviation 209 | CD4 T cell counts per mm^3 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Pomalidomide) | 26 | |
| Overall Study | COMPLETED | Treatment (Pomalidomide) | 8 | |
| Overall Study | NOT COMPLETED | Treatment (Pomalidomide) | 18 |
Source ClinicalTrials.gov
Adverse events29
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 | Diarrhea | Gastrointestinal disorders | Treatment (Pomalidomide) | 2 | 26 | 2 |
| other | Conjunctivitis infective | Infections and infestations | Treatment (Pomalidomide) | 2 | 26 | 3 |
| other | Wound infection | Infections and infestations | Treatment (Pomalidomide) | 2 | 26 | 2 |
| other | Lymphocite count decreased | Investigations | Treatment (Pomalidomide) | 2 | 26 | 2 |
| other | Lymphocyte count increased | Investigations | Treatment (Pomalidomide) | 3 | 26 | 5 |
| other | Neutrophil count decreased | Investigations | Treatment (Pomalidomide) | 14 | 26 | 25 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Treatment (Pomalidomide) | 2 | 26 | 2 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Treatment (Pomalidomide) | 2 | 26 | 4 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Treatment (Pomalidomide) | 3 | 26 | 4 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Treatment (Pomalidomide) | 3 | 26 | 3 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Pomalidomide) | 3 | 26 |
| Total, other adverse events | Treatment (Pomalidomide) | 23 | 26 |
| Total, serious adverse events | Treatment (Pomalidomide) | 7 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 |
Source NIH RePORTER
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/NCT03601806
GET https://conductscience.org/api/trials/v1/NCT03601806/events?page=2