Trial · NCT01057121

Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma

NCT01057121, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-07-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma. Trials, record NCT01057121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01057121

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma
NCT number: NCT01057121
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 38 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: AIDS-Related Kaposi Sarcoma, Recurrent Kaposi Sarcoma
Interventions: Lenalidomide
First posted: 2010-01-27
Last updated: 2022-02-08
Results first posted: 2016-07-21

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)	28 days	Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.
Primary	Tumor Response Rate	Up to 30 days after completion of study treatment	Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks. Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.
Secondary	Time to Death	Up to 30 days after completion of study treatment	Percentage of patients who died
Secondary	Time to Relapse	Up to 30 days after completion of study treatment	Percentage of participants who relapsed
Secondary	Time to Response	Up to 30 days after completion of study treatment	time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions.
Other	Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load	Up to 30 days after completion of study treatment	Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.

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	Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)	28 days	Only patients in the phase I portion of the study were evaluated for this outcome measure.	mg per day of lenalidomide	NUMBER
PRIMARY	Tumor Response Rate	Up to 30 days after completion of study treatment	Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.	percent of participants who responded	NUMBER
SECONDARY	Time to Death	Up to 30 days after completion of study treatment	Study participants who died on study.	percentage of participants who died	NUMBER
SECONDARY	Time to Relapse	Up to 30 days after completion of study treatment	Patients who relapsed
SECONDARY	Time to Response	Up to 30 days after completion of study treatment	Participants who had a complete or partial responses	weeks	MEDIAN
OTHER_PRE_SPECIFIED	Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load	Up to 30 days after completion of study treatment	The KSHV (HHV-8) assays were run, but the results were unreliable.

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)	Phase I - Treatment (Lenalidomide)	25		mg per day of lenalidomide
Tumor Response Rate	Phase I - 10 mg/Day (Lenalidomide)	0	95% Confidence Interval 0 to 0	percent of participants who responded
Tumor Response Rate	Phase I - 15 mg/Day (Lenalidomide)	0	95% Confidence Interval 0 to 0	percent of participants who responded
Tumor Response Rate	Phase I: 20 mg/Day Lenalidomide	50	95% Confidence Interval 1 to 99	percent of participants who responded
Tumor Response Rate	Phase I: 25 mg/Day Lenalidomide	80	95% Confidence Interval 28 to 99	percent of participants who responded
Tumor Response Rate	Phase II: 25 mg/Day Lenalidomide	53	95% Confidence Interval 30 to 75	percent of participants who responded
Time to Death	Phase I - 10 mg/Day Lenalidomide	0		percentage of participants who died
Time to Death	Phase I - 15 mg/Day Lenalidomide	0		percentage of participants who died
Time to Death	Phase I: 20 mg/Day Lenalidomide	0		percentage of participants who died
Time to Death	Phase I: 25 mg/Day Lenalidomide	0		percentage of participants who died

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow75

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase I: 10 mg/Day Lenalidomide	STARTED	Phase I: Treatment (Lenalidomide) , 10 mg/Day	3
Phase I: 10 mg/Day Lenalidomide	STARTED	Phase I: Treatment (Lenalidomide), 15 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	STARTED	Phase I, Treatment Ienalidomide), 20 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	STARTED	Phase I: Treatment (Lenalidomide), 25 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	STARTED	Phase II: Treatment (Lenalidomide), 25 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	COMPLETED	Phase I: Treatment (Lenalidomide) , 10 mg/Day	3
Phase I: 10 mg/Day Lenalidomide	COMPLETED	Phase I: Treatment (Lenalidomide), 15 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	COMPLETED	Phase I, Treatment Ienalidomide), 20 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	COMPLETED	Phase I: Treatment (Lenalidomide), 25 mg/Day	0
Phase I: 10 mg/Day Lenalidomide	COMPLETED	Phase II: Treatment (Lenalidomide), 25 mg/Day	0

1 to 10 of 75Source ClinicalTrials.gov

See all 75 participant flow

Adverse events256

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	Anemia	Blood and lymphatic system disorders	Phase I: 10 mg/Day Lenalidomide	0	3	0
other	Anemia	Blood and lymphatic system disorders	Phase I: 15 mg/Day Lenalidomide	0	3
other	Anemia	Blood and lymphatic system disorders	Phase I: 20 mg/Day Lenalidomide	2	3
other	Anemia	Blood and lymphatic system disorders	Phase I and II: 25 mg/Day Lenalidomide	7	29
other	Blood and Lymphatic disorders, other	Blood and lymphatic system disorders	Phase I: 10 mg/Day Lenalidomide	0	3	0
other	Blood and Lymphatic disorders, other	Blood and lymphatic system disorders	Phase I: 15 mg/Day Lenalidomide	0	3
other	Blood and Lymphatic disorders, other	Blood and lymphatic system disorders	Phase I: 20 mg/Day Lenalidomide	0	3
other	Blood and Lymphatic disorders, other	Blood and lymphatic system disorders	Phase I and II: 25 mg/Day Lenalidomide	4	29
other	Abdominal pain	Gastrointestinal disorders	Phase I: 10 mg/Day Lenalidomide	2	3	2
other	Abdominal pain	Gastrointestinal disorders	Phase I: 15 mg/Day Lenalidomide	0	3

1 to 10 of 256Source ClinicalTrials.gov

See all 256 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I: 10 mg/Day Lenalidomide
Total, all-cause mortality	Phase I: 15 mg/Day Lenalidomide
Total, all-cause mortality	Phase I: 20 mg/Day Lenalidomide
Total, all-cause mortality	Phase I and II: 25 mg/Day Lenalidomide
Total, other adverse events	Phase I: 10 mg/Day Lenalidomide	3	3
Total, other adverse events	Phase I: 15 mg/Day Lenalidomide	3	3
Total, other adverse events	Phase I: 20 mg/Day Lenalidomide	3	3
Total, other adverse events	Phase I and II: 25 mg/Day Lenalidomide	28	29
Total, serious adverse events	Phase I: 10 mg/Day Lenalidomide	0	3
Total, serious adverse events	Phase I: 15 mg/Day Lenalidomide	0	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35247913	DERIVED

Source PubMed

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
U01CA121947	AIDS Malignancy Clinical Trials Consortium (AMC)	MITSUYASU, RONALD T.	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL CANCER INSTITUTE	2006 to 2014

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01057121

GET https://conductscience.org/api/trials/v1/NCT01057121/flow?page=2

API reference For AI assistants