NCT01564784 · OUTCOME

Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia · Source last updated 2019-01-09

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: Up to approximately 4 weeks (EoT) from last dose of study drug

What was measured

Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.

Analysis population: Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi

Groups in this outcome

Inotuzumab Ozogamicin

Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).

Defined Investigator's Choice of Chemotherapy

Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.

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
Inotuzumab Ozogamicin	54
Defined Investigator's Choice of Chemotherapy	22

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Inotuzumab Ozogamicin	3.7	Not reported	0.5	12.7	Not reported
Defined Investigator's Choice of Chemotherapy	18.2	Not reported	5.2	40.3	Not reported

Source statistical analyses

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

group Description
Abnormal at Screening
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3168
statistical Comment
If any cell count is \<5, p-value was based on Fisher's exact test
statistical Method
1-sided p-value based on Chi-Square test
group Description
Abnormal after remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2160
statistical Comment
If any cell count is \<5, p-value was based on Fisher's exact test
statistical Method
1-sided p-value based on Chi-Square test

Complete source fields

analyses

group Description
Abnormal at Screening
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.3168
statistical Comment
If any cell count is \<5, p-value was based on Fisher's exact test
statistical Method
1-sided p-value based on Chi-Square test
group Description
Abnormal after remission
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2160
statistical Comment
If any cell count is \<5, p-value was based on Fisher's exact test
statistical Method
1-sided p-value based on Chi-Square test

classes

categories
measurements
group Id
OG000
lower Limit
0.5
upper Limit
12.7
value
3.7
group Id
OG001
lower Limit
5.2
upper Limit
40.3
value
18.2

denoms

counts
group Id
OG000
value
54
group Id
OG001
value
22
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
id
OG000
title
Inotuzumab Ozogamicin
description
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
id
OG001
title
Defined Investigator's Choice of Chemotherapy

param Type

NUMBER

population Description

Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi

reporting Status

POSTED

time Frame

Up to approximately 4 weeks (EoT) from last dose of study drug

title

Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)

type

SECONDARY

unit Of Measure

Percentage of Participants

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Preserved source evidence · Not medical advice