Trial · NCT01076543

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

NCT01076543, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma. Trials, record NCT01076543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01076543

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Trial

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

Title: Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
NCT number: NCT01076543
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 110 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: AIDS-Related Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Follicular Lymphoma, Recurrent Lymphoplasmacytic Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Waldenstrom Macroglobulinemia
Interventions: Laboratory Biomarker Analysis, Lenalidomide, Temsirolimus
First posted: 2010-02-26
Last updated: 2019-10-16
Results first posted: 2019-10-16

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	28 days	Incidence of dose-limiting toxicity (DLT) defined as any grade 3 or 4 adverse events as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
Primary	Complete Response (Phase II)	Up to 1 year	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions;
Primary	Overall Response Rate (Phase II)	Up to 1 year	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Progression-free Survival (PFS) (Phase II)	Time from study entry until disease progression or death from any cause, assessed up to 5 years	Kaplan-Meier curves will be generated for PFS stratified by histology; median PFS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.
Secondary	Overall Survival (OS) (Phase II)	Time from study entry until death from any cause, assessed up to 6 years	Kaplan-Meier curves will be generated for OS stratified by histology; median OS times will be determined and 90% confidence intervals derived as described in Brookmeyer and Crowley.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	28 days	Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Complete Response (Phase II)	Up to 1 year	Only phase II patients were assessed for complete response.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Response Rate (Phase II)	Up to 1 year	Only phase II patients were assessed for overall response.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival (PFS) (Phase II)	Time from study entry until disease progression or death from any cause, assessed up to 5 years	Note: Only phase II patients were followed for progression-free survival.	Months	MEDIAN
SECONDARY	Overall Survival (OS) (Phase II)	Time from study entry until death from any cause, assessed up to 6 years	Only phase II patients were followed for overall survival.~Note:999999 for the upper confidence interval of the median for the follicular subtype means not estimable.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Value	Units
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase I, All Histologies, Lenalidomide 15 mg	1	Participants
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase I, All Histologies, Lenalidomide 20 mg	0	Participants
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase I, All Histologies, Lenalidomide 25 mg	3	Participants
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase II, Diffuse Large B-Cell Subtype	0	Participants
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase II, Follicular Subtype	0	Participants
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only	Phase II, Lymphoma NOS	0	Participants
Complete Response (Phase II)	Phase I, All Histologies, Lenalidomide 15 mg	0	Participants
Complete Response (Phase II)	Phase I, All Histologies, Lenalidomide 20 mg	0	Participants
Complete Response (Phase II)	Phase I, All Histologies, Lenalidomide 25 mg	0	Participants
Complete Response (Phase II)	Phase II, Diffuse Large B-Cell Subtype	5	Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I, All Histologies, Lenalidomide 15 mg	8
Overall Study	STARTED	Phase I, All Histologies, Lenalidomide 20 mg	3
Overall Study	STARTED	Phase I, All Histologies, Lenalidomide 25 mg	6
Overall Study	STARTED	Phase II, Diffuse Large B-Cell Subtype	39
Overall Study	STARTED	Phase II, Follicular Subtype	15
Overall Study	STARTED	Phase II, Lymphoma NOS	39
Overall Study	COMPLETED	Phase I, All Histologies, Lenalidomide 15 mg	6
Overall Study	COMPLETED	Phase I, All Histologies, Lenalidomide 20 mg	3
Overall Study	COMPLETED	Phase I, All Histologies, Lenalidomide 25 mg	6
Overall Study	COMPLETED	Phase II, Diffuse Large B-Cell Subtype	39

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,410

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
other	Abdominal pain	Gastrointestinal disorders	Phase I, All Histologies, Lenalidomide 15 mg	1	8
other	Abdominal pain	Gastrointestinal disorders	Phase I, All Histologies, Lenalidomide 20 mg	1	3
other	Abdominal pain	Gastrointestinal disorders	Phase I, All Histologies, Lenalidomide 25 mg	1	6
other	Abdominal pain	Gastrointestinal disorders	Phase II, Diffuse Large B-Cell Subtype	9	39
other	Abdominal pain	Gastrointestinal disorders	Phase II, Follicular Subtype	1	15
other	Abdominal pain	Gastrointestinal disorders	Phase II, Lymphoma NOS	7	39
other	Alkaline aminotransferase increase	Investigations	Phase I, All Histologies, Lenalidomide 15 mg	4	8
other	Alkaline aminotransferase increase	Investigations	Phase I, All Histologies, Lenalidomide 20 mg	1	3
other	Alkaline aminotransferase increase	Investigations	Phase I, All Histologies, Lenalidomide 25 mg	2	6
other	Alkaline aminotransferase increase	Investigations	Phase II, Diffuse Large B-Cell Subtype	12	39

1 to 10 of 1,410Source ClinicalTrials.gov

See all 1,410 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I, All Histologies, Lenalidomide 15 mg	4	8
Total, all-cause mortality	Phase I, All Histologies, Lenalidomide 20 mg	3	3
Total, all-cause mortality	Phase I, All Histologies, Lenalidomide 25 mg	4	6
Total, all-cause mortality	Phase II, Diffuse Large B-Cell Subtype	23	39
Total, all-cause mortality	Phase II, Follicular Subtype	4	15
Total, all-cause mortality	Phase II, Lymphoma NOS	18	39
Total, other adverse events	Phase I, All Histologies, Lenalidomide 15 mg	8	8
Total, other adverse events	Phase I, All Histologies, Lenalidomide 20 mg	3	3
Total, other adverse events	Phase I, All Histologies, Lenalidomide 25 mg	6	6
Total, other adverse events	Phase II, Diffuse Large B-Cell Subtype	39	39

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34320785	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
P30CA014599	Cancer Center Support Grant	ODUNSI, KUNLE	UNIVERSITY OF CHICAGO	NATIONAL CANCER INSTITUTE	1985 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.

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/NCT01076543

GET https://conductscience.org/api/trials/v1/NCT01076543/results?page=2

API reference For AI assistants