NCT02165397 · OUTCOME

Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia · Source last updated 2021-03-03

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: Not reported
Time frame: Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)

What was measured

ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate.

Analysis population: Intent to Treat population: all randomized/enrolled participants

Groups in this outcome

Ibrutinib + Rituximab

Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.

Placebo + Rituximab

Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.

Open-Label Substudy: Ibrutinib

Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.

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
Ibrutinib + Rituximab	75
Placebo + Rituximab	75
Open-Label Substudy: Ibrutinib	31

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ibrutinib + Rituximab	76.0	Not reported	Not reported	Not reported	Not reported
Placebo + Rituximab	30.7	Not reported	Not reported	Not reported	Not reported
Open-Label Substudy: Ibrutinib	77.4	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
1.753
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.639
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
p Value Comment
Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.
param Type
Rate Ratio
param Value
2.526
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
1.753
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.639
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
< 0.0001
p Value Comment
Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.
param Type
Rate Ratio
param Value
2.526
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
76.0
group Id
OG001
value
30.7
group Id
OG002
value
77.4

denoms

counts
group Id
OG000
value
75
group Id
OG001
value
75
group Id
OG002
value
31
units
Participants

description

groups

description
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
id
OG000
title
Ibrutinib + Rituximab
description
Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
id
OG001
title
Placebo + Rituximab
description
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
id
OG002
title
Open-Label Substudy: Ibrutinib

param Type

NUMBER

population Description

Intent to Treat population: all randomized/enrolled participants

reporting Status

POSTED

time Frame

Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)

title

Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice