Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) · Source last updated 2024-03-05
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.
What was measured
Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?
Analysis population: All participants who received protocol-specified therapy analyzed according to the treatment they received.
Groups in this outcome
Standard of Care Chemotherapy
Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.
Blinatumomab
Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.
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
Standard of Care Chemotherapy
109
Blinatumomab
267
Reported measurements
Any adverse event
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
108
Not reported
Not reported
Not reported
Not reported
Blinatumomab
263
Not reported
Not reported
Not reported
Not reported
AE grade ≥ 2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
106
Not reported
Not reported
Not reported
Not reported
Blinatumomab
256
Not reported
Not reported
Not reported
Not reported
AE grade ≥ 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
100
Not reported
Not reported
Not reported
Not reported
Blinatumomab
231
Not reported
Not reported
Not reported
Not reported
AE grade ≥ 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
67
Not reported
Not reported
Not reported
Not reported
Blinatumomab
133
Not reported
Not reported
Not reported
Not reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
49
Not reported
Not reported
Not reported
Not reported
Blinatumomab
165
Not reported
Not reported
Not reported
Not reported
AEs leading to interruption of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
6
Not reported
Not reported
Not reported
Not reported
Blinatumomab
86
Not reported
Not reported
Not reported
Not reported
AEs leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
9
Not reported
Not reported
Not reported
Not reported
Blinatumomab
33
Not reported
Not reported
Not reported
Not reported
Life-threatening adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
26
Not reported
Not reported
Not reported
Not reported
Blinatumomab
55
Not reported
Not reported
Not reported
Not reported
Fatal adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
19
Not reported
Not reported
Not reported
Not reported
Blinatumomab
51
Not reported
Not reported
Not reported
Not reported
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
92
Not reported
Not reported
Not reported
Not reported
Blinatumomab
214
Not reported
Not reported
Not reported
Not reported
Treatment-related AE grade ≥ 2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
89
Not reported
Not reported
Not reported
Not reported
Blinatumomab
195
Not reported
Not reported
Not reported
Not reported
Treatment-related AE grade ≥ 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
78
Not reported
Not reported
Not reported
Not reported
Blinatumomab
143
Not reported
Not reported
Not reported
Not reported
Treatment-related AE grade ≥ 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
51
Not reported
Not reported
Not reported
Not reported
Blinatumomab
57
Not reported
Not reported
Not reported
Not reported
Serious treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
34
Not reported
Not reported
Not reported
Not reported
Blinatumomab
74
Not reported
Not reported
Not reported
Not reported
TRAEs leading to interruption of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
6
Not reported
Not reported
Not reported
Not reported
Blinatumomab
58
Not reported
Not reported
Not reported
Not reported
TRAEs leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
8
Not reported
Not reported
Not reported
Not reported
Blinatumomab
19
Not reported
Not reported
Not reported
Not reported
Treatment-related life-threatening adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
17
Not reported
Not reported
Not reported
Not reported
Blinatumomab
21
Not reported
Not reported
Not reported
Not reported
Treatment-related fatal adverse events
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Chemotherapy
8
Not reported
Not reported
Not reported
Not reported
Blinatumomab
8
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
108
group Id
OG001
value
263
title
Any adverse event
categories
measurements
group Id
OG000
value
106
group Id
OG001
value
256
title
AE grade ≥ 2
categories
measurements
group Id
OG000
value
100
group Id
OG001
value
231
title
AE grade ≥ 3
categories
measurements
group Id
OG000
value
67
group Id
OG001
value
133
title
AE grade ≥ 4
categories
measurements
group Id
OG000
value
49
group Id
OG001
value
165
title
Serious adverse events
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
86
title
AEs leading to interruption of study drug
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
33
title
AEs leading to discontinuation of study drug
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
55
title
Life-threatening adverse events
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
51
title
Fatal adverse events
categories
measurements
group Id
OG000
value
92
group Id
OG001
value
214
title
Treatment-related adverse events
categories
measurements
group Id
OG000
value
89
group Id
OG001
value
195
title
Treatment-related AE grade ≥ 2
categories
measurements
group Id
OG000
value
78
group Id
OG001
value
143
title
Treatment-related AE grade ≥ 3
denoms
counts
group Id
OG000
value
109
group Id
OG001
value
267
units
Participants
description
Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?
groups
description
Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.
id
OG000
title
Standard of Care Chemotherapy
description
Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab.
Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period.
The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.
id
OG001
title
Blinatumomab
param Type
NUMBER
population Description
All participants who received protocol-specified therapy analyzed according to the treatment they received.
reporting Status
POSTED
time Frame
From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.
Triangle