NCT01076543 · OUTCOME

Complete Response (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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 1 year

What was measured

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;

Analysis population: Only phase II patients were assessed for complete response.

Groups in this outcome

Phase I, All Histologies, Lenalidomide 15 mg

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. .

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 Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I, All Histologies, Lenalidomide 15 mg	0	Not reported	Not reported	Not reported	Not reported
Phase I, All Histologies, Lenalidomide 20 mg	0	Not reported	Not reported	Not reported	Not reported
Phase I, All Histologies, Lenalidomide 25 mg	0	Not reported	Not reported	Not reported	Not reported
Phase II, Diffuse Large B-Cell Subtype	5	Not reported	Not reported	Not reported	Not reported
Phase II, Follicular Subtype	5	Not reported	Not reported	Not reported	Not reported
Phase II, Lymphoma NOS	7	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
5
group Id
OG004
value
5
group Id
OG005
value
7

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

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;

groups

description
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. .
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

COUNT_OF_PARTICIPANTS

population Description

Only phase II patients were assessed for complete response.

reporting Status

POSTED

time Frame

Up to 1 year

title

Complete Response (Phase II)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice