NCT01456039 · OUTCOME

Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015

What was measured

Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is \>75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease

Analysis population: Intent to treat population for participants with PTCL who received at least one dose of Romidepsin

Groups in this outcome

Phase 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

Phase 1: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Phase 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Total: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

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 1: Romidepsin 9mg/m^2	2
Phase 1: Romidepsin 14mg/m^2	6
Phase 2: Romidepsin 14mg/m^2	40
Total: Romidepsin 14mg/m^2	46

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Romidepsin 9mg/m^2	0	Not reported	0.000	0.000	Not reported
Phase 1: Romidepsin 14mg/m^2	66.7	Not reported	28.947	100.000	Not reported
Phase 2: Romidepsin 14mg/m^2	42.5	Not reported	27.180	57.820	Not reported
Total: Romidepsin 14mg/m^2	45.7	Not reported	31.258	60.046	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
p Value Comment
Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)
statistical Method
Binomial test for dichotomized response

Complete source fields

analyses

group Ids
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
p Value Comment
Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)
statistical Method
Binomial test for dichotomized response

classes

categories
measurements
group Id
OG000
lower Limit
0.000
upper Limit
0.000
value
0
group Id
OG001
lower Limit
28.947
upper Limit
100.000
value
66.7
group Id
OG002
lower Limit
27.180
upper Limit
57.820
value
42.5
group Id
OG003
lower Limit
31.258
upper Limit
60.046
value
45.7

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
6
group Id
OG002
value
40
group Id
OG003
value
46
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
id
OG000
title
Phase 1: Romidepsin 9mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG001
title
Phase 1: Romidepsin 14mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG002
title
Phase 2: Romidepsin 14mg/m^2
description
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
id
OG003
title
Total: Romidepsin 14mg/m^2

param Type

NUMBER

population Description

Intent to treat population for participants with PTCL who received at least one dose of Romidepsin

reporting Status

POSTED

time Frame

Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015

title

Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2

type

PRIMARY

unit Of Measure

percentage of participants

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