Trial Outcomes & Findings for Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions (NCT NCT04198623)
NCT ID: NCT04198623
Last Updated: 2025-12-15
Results Overview
The incidence rate of infusion reaction includes all clinical sign and symptoms of reaction graded by CTCAE v5.0 in patients receiving each cycle monoclonal antibody infusions. The grade and rate of each grade will be measured and or calculated for each cycle of infusion up to 6 cycles or treatment discontinuation which ever comes first
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Through study completion (average 6 months)
Results posted on
2025-12-15
Participant Flow
Hematology and Oncology Clinic of Community Cancer Institute
Patients with hematologic disorders or malignancies starting on any of the following monoclonal antibodies alone or in combination with chemotherapy (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab
Participant milestones
| Measure |
Open Label Single Arm Treatment Group
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Open Label Single Arm Treatment Group
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|
|
Overall Study
1 patient was taken off due to covid-19 pandemic shut down
|
1
|
Baseline Characteristics
Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
Baseline characteristics by cohort
| Measure |
Open Label Single Arm Treatment Group
n=40 Participants
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6009 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=6009 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=6009 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 15.9 • n=6009 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=6009 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=6009 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=6009 Participants
|
|
Medication allergy
At least 1 medication allergy
|
15 Participants
n=6009 Participants
|
|
Medication allergy
No Medication allergy
|
25 Participants
n=6009 Participants
|
|
At least 1 Atopic Condition (
Present
|
7 Participants
n=6009 Participants
|
|
At least 1 Atopic Condition (
Absent
|
33 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Rituximab
|
21 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Daratumumab
|
7 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Blinatumomab
|
3 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Gemtuzumab
|
5 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Elotuzumab
|
1 Participants
n=6009 Participants
|
|
Monoclonal Antibody Treatment
Obinutuzumab
|
3 Participants
n=6009 Participants
|
|
Diagnosis
Follicular lymphoma
|
3 Participants
n=6009 Participants
|
|
Diagnosis
Diffuse Large B cell Lymphoma
|
12 Participants
n=6009 Participants
|
|
Diagnosis
Marginal Zone Lymphoma
|
4 Participants
n=6009 Participants
|
|
Diagnosis
Multiple Myeloma/amyloidosis
|
8 Participants
n=6009 Participants
|
|
Diagnosis
CLL
|
2 Participants
n=6009 Participants
|
|
Diagnosis
ALL
|
3 Participants
n=6009 Participants
|
|
Diagnosis
AML
|
6 Participants
n=6009 Participants
|
|
Diagnosis
ITP/AIHA
|
2 Participants
n=6009 Participants
|
PRIMARY outcome
Timeframe: Through study completion (average 6 months)Population: The incidence rate of all grades of infusion reaction on the day of infusion during or after administration of cycle 1 of Monoclonal Antibody treatment in all participants
The incidence rate of infusion reaction includes all clinical sign and symptoms of reaction graded by CTCAE v5.0 in patients receiving each cycle monoclonal antibody infusions. The grade and rate of each grade will be measured and or calculated for each cycle of infusion up to 6 cycles or treatment discontinuation which ever comes first
Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Participants
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
Cycle 1 infusion reaction · Infusion reaction
|
14 Participants
|
—
|
|
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
Cycle 1 infusion reaction · No infusion reaction
|
26 Participants
|
—
|
|
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
Cycle 2-6 infusion reaction · Infusion reaction
|
4 Participants
|
—
|
|
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
Cycle 2-6 infusion reaction · No infusion reaction
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: Through study completion (average 6 months)Population: Total population is separated to the differing monoclonal antibody treatment regimen
The time from start to end of each cycle of infusion of monoclonal antibody will be measured in the study subject up to 6 cycles or treatment discontinuation which ever comes first. Average infusion time will then be calculated.
Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Number of infusion
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
n=152 Number of infusion
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Elotuzumab infusions
|
176 minutes
Standard Deviation NA
Only one data point captured for this instance
|
68.0 minutes
Standard Deviation 11.4
|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Rituximab infusions
|
267.0 minutes
Standard Deviation 151.0
|
194.0 minutes
Standard Deviation 70.3
|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Obinutuzumab infusions
|
311.0 minutes
Standard Deviation 56.0
|
218.5 minutes
Standard Deviation 18.0
|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Daratumumab infusions
|
110.0 minutes
Standard Deviation 132.0
|
87.4 minutes
Standard Deviation 103.7
|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Gemtuzumab infusions
|
162.8 minutes
Standard Deviation 59.7
|
292.4 minutes
Standard Deviation 391.4
|
|
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Blinatumomab infusions
|
60.0 minutes
Standard Deviation 84.3
|
115.5 minutes
Standard Deviation 244.0
|
SECONDARY outcome
Timeframe: Through study completion (average 6 months)Population: Patient who had infusion reaction
The incidence rate of Grade 3 infusion reaction includes all clinical sign and symptoms of reaction graded by CTCAE v5.0 as grade 3 in patients receiving all monoclonal antibodies through out the entire duration of treatment(up to 6 cycles or till treatment is discontinue which ever comes first
Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Participants
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (all grades) of cycle 1 · Infusion reactions
|
14 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (all grades) of cycle 1 · No infusion reactions
|
26 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (grade 3 or greater) of cycle 1 · Infusion reactions
|
4 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (grade 3 or greater) of cycle 1 · No infusion reactions
|
36 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (all grades) of cycle 2-6 · Infusion reactions
|
4 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (grade 3 or greater) of cycle 2-6 · Infusion reactions
|
0 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (grade 3 or greater) of cycle 2-6 · No infusion reactions
|
40 Participants
|
—
|
|
Incidence Rate of Grade 3 or More Monoclonal Antibody Infusion Throughout the Entire Duration of Infusion (up to 6 Cycles or Till Discontinuation Whichever Comes First)
Infusion reactions (all grades) of cycle 2-6 · No infusion reactions
|
36 Participants
|
—
|
SECONDARY outcome
Timeframe: Through study completion (average 6 months)Rate at which monoclonal antibody treatment is stopped and changed to new treatment due to adverse drug reaction attributed to monoclonal antibody infusion
Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Participants
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Discontinuation Rate of Monoclonal Antibody Infusion Due to SIRs
No
|
37 Participants
|
—
|
|
Discontinuation Rate of Monoclonal Antibody Infusion Due to SIRs
Yes
|
3 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Participants
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Infusion Data Cycle 1
Rituximab
|
21 Participants
|
—
|
|
Infusion Data Cycle 1
Daratumumab
|
7 Participants
|
—
|
|
Infusion Data Cycle 1
Gemtuzumab
|
5 Participants
|
—
|
|
Infusion Data Cycle 1
Obinutuzumab
|
3 Participants
|
—
|
|
Infusion Data Cycle 1
Blinatumomab
|
3 Participants
|
—
|
|
Infusion Data Cycle 1
Elotuzumab
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 2-6Population: 1 patient was taken off study due to covid-19 pandemic and suspension of non-essential clinical trial
Outcome measures
| Measure |
Montelukast (Singulair)
n=40 Participants
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
Open Label Single Arm Treatment Group - Cycles 2-6
Phase II single arm open label study evaluating 10 mg Montelukast given at least 1 hour prior to infusion of each dose of Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab) in addition to standard premedication up to 6 doses
|
|---|---|---|
|
Infusion Data Cycle 2-6
Rituximab
|
20 Participants
|
—
|
|
Infusion Data Cycle 2-6
Daratumumab
|
7 Participants
|
—
|
|
Infusion Data Cycle 2-6
Gemtuzumab
|
5 Participants
|
—
|
|
Infusion Data Cycle 2-6
Obinutuzumab
|
3 Participants
|
—
|
|
Infusion Data Cycle 2-6
Blinatumomab
|
3 Participants
|
—
|
|
Infusion Data Cycle 2-6
Elotuzumab
|
1 Participants
|
—
|
|
Infusion Data Cycle 2-6
Removed from study
|
1 Participants
|
—
|
Adverse Events
Montelukast (Singulair)
Serious events: 12 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast (Singulair)
n=40 participants at risk
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
|---|---|
|
Immune system disorders
Infusion reaction
|
30.0%
12/40 • Number of events 12 • 6 months post start of cycle 1 of infusion
National Cancer Institute Common Terminology of Standard Adverse Effect (NCI CTCAE v5.0)
|
Other adverse events
| Measure |
Montelukast (Singulair)
n=40 participants at risk
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Montelukast 10 Mg Oral Tablet: Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
|
|---|---|
|
Immune system disorders
National Cancer Institute Common Terminology of Standard Adverse Effect (NCI CTCAE v5.0)
|
5.0%
2/40 • Number of events 2 • 6 months post start of cycle 1 of infusion
National Cancer Institute Common Terminology of Standard Adverse Effect (NCI CTCAE v5.0)
|
Additional Information
Mohammed Sani Bukari MD, Associate clinical professor
UCSF Fresno/Community Cancer Institute
Phone: 3473019055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place