Trial Outcomes & Findings for Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection (NCT NCT03601806)
NCT ID: NCT03601806
Last Updated: 2026-04-13
Results Overview
The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 48 weeks
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Treatment (Pomalidomide)
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Treatment (Pomalidomide)
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
Baseline characteristics by cohort
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Age, Continuous
|
38.7 years old
n=193 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
Malawi
|
15 participants
n=193 Participants
|
|
Region of Enrollment
Uganda
|
5 participants
n=193 Participants
|
|
Region of Enrollment
Kenya
|
6 participants
n=193 Participants
|
|
CD4 cells at baseline
CD4 cells >200/uL
|
24 Participants
n=193 Participants
|
|
CD4 cells at baseline
CD4 cells <=200/uL
|
2 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Study participants who received study treatment
The binomial proportion and its 95% exact confidence interval will be used to estimate the overall response rate.
Outcome measures
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Overall Response Rate
|
0.577 proportion of participants
Interval 0.369 to 0.766
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Study participants who received study treatment
The binomial proportion and its 95% exact confidence interval will be used to estimate the complete response rate
Outcome measures
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Complete Response Rate
|
0 proportion of participants
Interval 0.0 to 0.16
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Study participants who received study treatment
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.
Outcome measures
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
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
All adverse events
|
57.7 percentage of participants
Interval 37.2 to 76.0
|
|
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-related adverse events
|
38.5 percentage of participants
Interval 20.9 to 59.3
|
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: Participants with CD4 measurement at baseline and 1 year
Changes in CD4 counts and human immunodeficiency virus (HIV) viral load will be evaluated.
Outcome measures
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Changes in CD4 T Cell Count
Baseline
|
456 CD4 T cell counts per mm^3
Standard Deviation 247.5
|
|
Changes in CD4 T Cell Count
Cycle 2 Day 1
|
524.1 CD4 T cell counts per mm^3
Standard Deviation 194.2
|
|
Changes in CD4 T Cell Count
Cycle4 Day 1
|
512.6 CD4 T cell counts per mm^3
Standard Deviation 251.5
|
|
Changes in CD4 T Cell Count
Cycle 7 Day 1
|
587.8 CD4 T cell counts per mm^3
Standard Deviation 327.3
|
|
Changes in CD4 T Cell Count
Cycle 10 Day 1
|
417.4 CD4 T cell counts per mm^3
Standard Deviation 203
|
|
Changes in CD4 T Cell Count
Treatment Discontinuation
|
484.6 CD4 T cell counts per mm^3
Standard Deviation 209
|
SECONDARY outcome
Timeframe: Baseline to up to 1 yearPopulation: Participants with HIV viral load measurement at baseline and 1 year
Changes in CD4 counts and HIV viral load will be evaluated.
Outcome measures
| Measure |
Treatment (Pomalidomide)
n=26 Participants
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Baseline
|
34.9 HIV viral load copies per mL
Standard Deviation 62
|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Cycle 2 Day 1
|
31.4 HIV viral load copies per mL
Standard Deviation 33.5
|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Cycle 4 Day 1
|
31.5 HIV viral load copies per mL
Standard Deviation 24.8
|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Cycle 7 Day 1
|
23.2 HIV viral load copies per mL
Standard Deviation 27.8
|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Cycle 10 Day 1
|
27.5 HIV viral load copies per mL
Standard Deviation 21.2
|
|
Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction
Treatment Discontinuation
|
39.1 HIV viral load copies per mL
Standard Deviation 12.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 48 weeksGeneral 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.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Pomalidomide)
Serious events: 7 serious events
Other events: 23 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Pomalidomide)
n=26 participants at risk
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Eye disorders
Eye disorders
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Eye disorders
Eye pain
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
General disorders
Death NOS
|
7.7%
2/26 • Number of events 2 • Up to 1 year
|
|
General disorders
Fever
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Infections and infestations
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Skin infection
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
|
Social circumstances
Social circumstances
|
3.8%
1/26 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Treatment (Pomalidomide)
n=26 participants at risk
Patients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Pomalidomide: Given PO
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
2/26 • Number of events 2 • Up to 1 year
|
|
Infections and infestations
Conjunctivitis infective
|
7.7%
2/26 • Number of events 3 • Up to 1 year
|
|
Infections and infestations
Wound infection
|
7.7%
2/26 • Number of events 2 • Up to 1 year
|
|
Investigations
Lymphocite count decreased
|
7.7%
2/26 • Number of events 2 • Up to 1 year
|
|
Investigations
Lymphocyte count increased
|
11.5%
3/26 • Number of events 5 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
53.8%
14/26 • Number of events 25 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
2/26 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
2/26 • Number of events 4 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.5%
3/26 • Number of events 4 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.5%
3/26 • Number of events 3 • Up to 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
4/26 • Number of events 4 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
6/26 • Number of events 7 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
42.3%
11/26 • Number of events 18 • Up to 1 year
|
Additional Information
Dr. Deukwoo Kwon
Consortium for Advancing Management and Prevention of Cancer in People with HIV
Phone: 501 526-6724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place