NCT01076543 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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)

Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).

→

primary · POSTED

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;

Only phase II patients were assessed for complete response.

→

primary · POSTED

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.

Only phase II patients were assessed for overall response.

→

secondary · POSTED

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.

Note: Only phase II patients were followed for progression-free survival.

→

secondary · POSTED

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.

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."

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-aids-related-lymphoma
nct id: NCT01076543
trial label: Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
source section id
NCT01076543-om-0000
source outcome index
0
endpoint
Incidence of Dose-limiting Toxicity (DLT), Phase I Patients Only
endpoint definition
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)
time origin
28 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only phase I patients were assessed for dose-limiting toxicity per 3+3 dose-escalation design to determine the maximum tolerated dose (MTD).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
source section id
NCT01076543-om-0001
source outcome index
1
endpoint
Complete Response (Phase II)
endpoint definition
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;
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only phase II patients were assessed for complete response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0002
source section id
NCT01076543-om-0002
source outcome index
2
endpoint
Overall Response Rate (Phase II)
endpoint definition
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.
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only phase II patients were assessed for overall response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0003
source section id
NCT01076543-om-0003
source outcome index
3
endpoint
Progression-free Survival (PFS) (Phase II)
endpoint definition
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.
time origin
Time from study entry until disease progression or death from any cause, assessed up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Note: Only phase II patients were followed for progression-free survival.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0004
source section id
NCT01076543-om-0004
source outcome index
4
endpoint
Overall Survival (OS) (Phase II)
endpoint definition
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.
time origin
Time from study entry until death from any cause, assessed up to 6 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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."
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG000
arm label
Phase I, All Histologies, Lenalidomide 15 mg
regimen
Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG001
arm label
Phase I, All Histologies, Lenalidomide 20 mg
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG002
arm label
Phase I, All Histologies, Lenalidomide 25 mg
regimen
Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG003
arm label
Phase II, Diffuse Large B-Cell Subtype
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG004
arm label
Phase II, Follicular Subtype
regimen
Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0000
arm key
OG005
arm label
Phase II, Lymphoma NOS
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG000
arm label
Phase I, All Histologies, Lenalidomide 15 mg
regimen
Patients receive lenalidomide 15 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG001
arm label
Phase I, All Histologies, Lenalidomide 20 mg
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG002
arm label
Phase I, All Histologies, Lenalidomide 25 mg
regimen
Patients receive lenalidomide 25 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG003
arm label
Phase II, Diffuse Large B-Cell Subtype
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG004
arm label
Phase II, Follicular Subtype
regimen
Patients receive lenalidomide 20mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
outcome key
om-0001
arm key
OG005
arm label
Phase II, Lymphoma NOS
regimen
Patients receive lenalidomide 20 mg PO on days 1-21 and 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. .
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01076543-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG000
source section id
NCT01076543-ae
event group key
EG000
event group label
Phase I, All Histologies, Lenalidomide 15 mg
serious affected
2
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG001
source section id
NCT01076543-ae
event group key
EG001
event group label
Phase I, All Histologies, Lenalidomide 20 mg
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG002
source section id
NCT01076543-ae
event group key
EG002
event group label
Phase I, All Histologies, Lenalidomide 25 mg
serious affected
5
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG003
source section id
NCT01076543-ae
event group key
EG003
event group label
Phase II, Diffuse Large B-Cell Subtype
serious affected
22
serious at risk
39
other affected
39
other at risk
39
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG004
source section id
NCT01076543-ae
event group key
EG004
event group label
Phase II, Follicular Subtype
serious affected
7
serious at risk
15
other affected
13
other at risk
15
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-aids-related-lymphoma
nct id
NCT01076543
harm key
EG005
source section id
NCT01076543-ae
event group key
EG005
event group label
Phase II, Lymphoma NOS
serious affected
22
serious at risk
39
other affected
39
other at risk
39
frequency threshold
5
collection period
Mortality collected up to 6 years; all other AEs collected up to 2 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice