NCT01076543 · OUTCOME

Overall Survival (OS) (Phase II)

Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma · Source last updated 2019-10-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: 90% Confidence Interval
Time frame: Time from study entry until death from any cause, assessed up to 6 years

What was measured

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.

Analysis population: 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."

Groups in this outcome

Phase I, All Histologies, Lenalidomide 15 mg

Patients receive lenalidomide 15 mg PO on days 1-21 and25 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. .

Phase I, All Histologies, Lenalidomide 20 mg

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. .

Phase I, All Histologies, Lenalidomide 25 mg

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. .

Phase II, Diffuse Large B-Cell Subtype

Phase II, Follicular Subtype

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. .

Phase II, Lymphoma NOS

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase I, All Histologies, Lenalidomide 15 mg	0
Phase I, All Histologies, Lenalidomide 20 mg	0
Phase I, All Histologies, Lenalidomide 25 mg	0
Phase II, Diffuse Large B-Cell Subtype	39
Phase II, Follicular Subtype	15
Phase II, Lymphoma NOS	39

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase II, Diffuse Large B-Cell Subtype	9.1	Not reported	6.0	16.0	Not reported
Phase II, Follicular Subtype	35.8	Not reported	18.8	NA	The upper confidence limit could not be determined due to the censoring.
Phase II, Lymphoma NOS	25.5	Not reported	10.8	60.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG003
lower Limit
6.0
upper Limit
16.0
value
9.1
comment
The upper confidence limit could not be determined due to the censoring.
group Id
OG004
lower Limit
18.8
upper Limit
NA
value
35.8
group Id
OG005
lower Limit
10.8
upper Limit
60.6
value
25.5

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
39
group Id
OG004
value
15
group Id
OG005
value
39
units
Participants

description

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.

dispersion Type

90% Confidence Interval

groups

description
Patients receive lenalidomide 15 mg PO on days 1-21 and25 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. .
id
OG000
title
Phase I, All Histologies, Lenalidomide 15 mg
description
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. .
id
OG001
title
Phase I, All Histologies, Lenalidomide 20 mg
description
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. .
id
OG002
title
Phase I, All Histologies, Lenalidomide 25 mg
description
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. .
id
OG003
title
Phase II, Diffuse Large B-Cell Subtype
description
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. .
id
OG004
title
Phase II, Follicular Subtype
description
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. .
id
OG005
title
Phase II, Lymphoma NOS

param Type

MEDIAN

population Description

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."

reporting Status

POSTED

time Frame

Time from study entry until death from any cause, assessed up to 6 years

title

Overall Survival (OS) (Phase II)

type

SECONDARY

unit Of Measure

Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice