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Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
Phase 2 trial testing Laboratory Biomarker Analysis in Human Immunodeficiency Virus 1 Positive in 26 participants. Completed in 10 April 2025.
| Lead sponsor | AIDS Malignancy Consortium |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 26 April 2021 |
| Primary completion | 29 November 2024 |
| Estimated completion | 10 April 2025 |
| Sites | 3 locations across Kenya, Malawi, Uganda |
AIDS Malignancy Consortium
18 and older, any sex, with Human Immunodeficiency Virus 1 Positive or Skin Kaposi Sarcoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 0.577 | 0.369 – 0.766 |
The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 0 | 0 – 0.16 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 57.7 | 37.2 – 76 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 38.5 | 20.9 – 59.3 |
Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 456 | ± 247.5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 524.1 | ± 194.2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 512.6 | ± 251.5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 587.8 | ± 327.3 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 417.4 | ± 203 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 484.6 | ± 209 |
Changes in CD4 counts and HIV viral load will be evaluated.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 34.9 | ± 62 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 31.4 | ± 33.5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 31.5 | ± 24.8 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 23.2 | ± 27.8 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 27.5 | ± 21.2 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Pomalidomide) | 39.1 | ± 12.6 |
Time frame: Up to 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Pomalidomide) |
|---|---|---|
| Death NOS | General disorders | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| Eye disorders | Eye disorders | — |
| Eye pain | Eye disorders | — |
| Fever | General disorders | — |
| Infections and infestations | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Tumor hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Syncope | Nervous system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Social circumstances | Social circumstances | — |
| Reaction | System | Treatment (Pomalidomide) |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Lymphocyte count increased | Investigations | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Conjunctivitis infective | Infections and infestations | — |
| Wound infection | Infections and infestations | — |
| Lymphocite count decreased | Investigations | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Death NOS, Blood and lymphatic system disorders, Eye disorders, Eye pain, Fever, Infections and infestations, Skin infection, Neutrophil count decreased.
Data from ClinicalTrials.gov NCT03601806 adverse events section.
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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