NCT00586924 · OUTCOME

Duration of Objective Response

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia · Source last updated 2019-04-02

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)

What was measured

Duration of response was measured from the first documentation of objective response (OR) to the first documented non-response of SD, PD, or relapse and was only evaluated in participants who had achieved an OR (CR or PR). Duration of OR was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).

Analysis population: Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved an OR (CR or PR) and had the first documented non-response of SD, PD, or relapse.

Groups in this outcome

5 mcg/kg

Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

10 mcg/kg

Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

20 mcg/kg

Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

30 mcg/kg

Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

40 mcg/kg

Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

50 mcg/kg

Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.

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
5 mcg/kg	1
10 mcg/kg	1
20 mcg/kg	1
30 mcg/kg	1
40 mcg/kg	0
50 mcg/kg	6

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
5 mcg/kg	8.34	Not reported	NA	NA	Not estimable because insufficient number of participants have events (progressed or relapsed).
10 mcg/kg	84.44	Not reported	NA	NA	Not estimable because insufficient number of participants have events (progressed or relapsed).
20 mcg/kg	80.95	Not reported	NA	NA	Not estimable because insufficient number of participants have events (progressed or relapsed).
30 mcg/kg	78.29	Not reported	NA	NA	Not estimable because insufficient number of participants have events (progressed or relapsed).
50 mcg/kg	NA	Not reported	52.11	NA	Not estimable because insufficient number of participants have events (progressed or relapsed).

Complete source fields

classes

categories
measurements
comment
Not estimable because insufficient number of participants have events (progressed or relapsed).
group Id
OG000
lower Limit
NA
upper Limit
NA
value
8.34
comment
Not estimable because insufficient number of participants have events (progressed or relapsed).
group Id
OG001
lower Limit
NA
upper Limit
NA
value
84.44
comment
Not estimable because insufficient number of participants have events (progressed or relapsed).
group Id
OG002
lower Limit
NA
upper Limit
NA
value
80.95
comment
Not estimable because insufficient number of participants have events (progressed or relapsed).
group Id
OG003
lower Limit
NA
upper Limit
NA
value
78.29
comment
Not estimable because insufficient number of participants have events (progressed or relapsed).
group Id
OG005
lower Limit
52.11
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
0
group Id
OG005
value
6
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG000
title
5 mcg/kg
description
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG001
title
10 mcg/kg
description
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG002
title
20 mcg/kg
description
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG003
title
30 mcg/kg
description
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG004
title
40 mcg/kg
description
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
id
OG005
title
50 mcg/kg

param Type

MEDIAN

population Description

Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved an OR (CR or PR) and had the first documented non-response of SD, PD, or relapse.

reporting Status

POSTED

time Frame

From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)

title

Duration of Objective Response

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice