Infusion ReactionPhase 2NCT04198623
Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
A Phase 2 study testing Montelukast 10 Mg Oral Tablet in people with Infusion Reaction and Monoclonal Antibody, run by University of California, San Francisco at 1 site in United States.
Trial summary
The use of monoclonal antibodies (MA) either alone or as part of chemoimmunotherapy in oncology, benign and malignant hematology is expanding. Of the 17 therapeutic MAs approved in 2017 by FDA, 50% of them are indicated for hematologic and oncologic condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infusion Reaction, Monoclonal Antibody
- What is being tested?
- Montelukast 10 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2020to 31 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 18 years.
- Able to provide consent for study participation (English and Spanish).
- 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).
- Able to tolerate leukotriene antagonist including Montelukast.
- Able to tolerate oral intake.
- Available for follow up by phone and on site.
Who cannot join
- Patients undergoing treatment with above monoclonal antibodies for indications other than stated in above eligibility criteria.
- Patients who cannot provide informed consent in English or Spanish.
- Patients taking Montelukast or other leukotriene antagonists for other indications at the time of screening.
- Known allergic reactions to Montelukast or other leukotriene inhibitors.
- On monoclonal antibodies other than the ones being studied (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab).
- History of uncontrolled depression or suicidal ideation or psychiatric illness.
Show all 11Show fewer
- Known Severe Hepatic Impairment (AST>10x ULN; ALT>10x ULN; ALP>10x ULN; and/or Bilirubin >5x ULN).
- Patient with eosinophilic vasculitis.
- Unable to comply with phone or in person follow-up.
- Patients participating in another clinical trial.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Cancer Institute
Clovis, California, 93611
About this study
Official title: A Phase II Study, Evaluating the Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
The use of monoclonal antibodies (MA) either alone or as part of chemoimmunotherapy in oncology, benign and malignant hematology is expanding. Of the 17 therapeutic MAs approved in 2017 by FDA, 50% of them are indicated for hematologic and oncologic condition. With increasing number of approved agents, therapeutic MAs have become one of the fastest growing areas in the management of benign and malignant hematologic condition. Advancement of recombinant technology allows development of partially or fully humanized new agents. Despite this, they still carry significant risk of immune and non-immune mediated adverse events. Most of the therapeutic monoclonal antibody related adverse events (MCAAE) The severity of reaction is variable, ranging from mild involvement of single organ to severe and life-threatening reactions requiring hospitalization or even resulting in death.
Even for mild infusion reactions, where re-initiation of infusion is possible, there is resultant delay in delivery of infusions, distress to patients, and additional utilization of health care resources.
Read more
Due to unpredictability of standard infusion reaction (SIR), efforts have been focused on premedication to decreasing the incidence and severity of infusion reaction. Most institutions have protocols using corticosteroid, acetaminophen and antihistamine as part of their premedication protocols. This has reduced but not eliminated standard infusion reactions. Most recently, mast cell stabilizers are being added to standard protocols to further reduce the incidence and severity of standard infusion reactions with variable anecdotal success without formal study. Of all the monoclonal antibodies, only Daratumumab has been evaluated using this strategy.
This study seeks to evaluate the efficacy of mast cell stabilizer Montelukast (SINGULAIR) 10 mg in decreasing the SIR in patients receiving therapeutic MAs either alone or as part of chemoimmunotherapy in hematologic condition. The MAs being studied includes: Blinatumomab (BLINCYTO, Amgen Inc.), Daratumumab (DARZALEX, Janssen Biotech, Inc.), Elotuzumab (EMPLICIT, Bristol-Myers Squibb Company), Gemtuzumab (MYLOTARG, Pfizer Inc.), Obinutuzumab (GAZYVA, Genentech USA, Inc.), and Rituximab (RITUXAN, Genentech US); The investigators postulate that 10 mg of Montelukast, when given in addition to standard premedication, will lead to decrease in incidence of MA associated SIR, shorter infusion time and decrease use of additional health care resources
Read the detailed description
Study design:
This is a Phase II single arm open label study evaluating 10 mg Montelukast given at least 2 hours prior to infusion of monoclonal antibody in addition to standard premedication. Monoclonal antibodies being evaluated include those commonly used to treat hematologic and oncologic malignancies like (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab).
Arms/Intervention; Study subjects will be given 10 mg of Montelukast to be orally self-administered at least 2 hours prior to beginning of chemotherapy section Standard premedication will be administered according to institution protocol
- Conditions
- Infusion Reaction, Monoclonal Antibody
- Being tested
- Montelukast 10 Mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10 Mg Oral TabletDrug
Also called Singulair
Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
| Study group | Role | What they receive |
|---|---|---|
| Montelukast (Singulair) | Other | Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication Receives: Drug: Montelukast 10 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
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
Measured: Through study completion (average 6 months)
Secondary outcomes (3)
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
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.
Measured: Through study completion (average 6 months)
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)
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
Measured: Through study completion (average 6 months)
Discontinuation Rate of Monoclonal Antibody Infusion Due to SIRs
Rate at which monoclonal antibody treatment is stopped and changed to new treatment due to adverse drug reaction attributed to monoclonal antibody infusion
Measured: Through study completion (average 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start20 Mar 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infusion ReactionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Bukari, MD, University of California, San Francisco
- Investigators
- MOHAMMED BUKARI, MD, Principal investigator, UCSF - Fresno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198623
- Sponsor's protocol ID
- IRB2019105
- Other IDs
- IND146287
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2019
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incidence rate of Infusion reaction Tolerability of infusion reaction
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study, Evaluating the Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
- ClinicalTrials.gov ID
- NCT04198623
- Acronym / sponsor ID
- IRB2019105
- Conditions
- Infusion Reaction, Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of monoclonal antibodies (MA) either alone or as part of chemoimmunotherapy in oncology, benign and malignant hematology is expanding. Of the 17 therapeutic MAs approved in 2017 by FDA, 50% of them are indicated for hematologic and oncologic condition. With increasing number of approved agents, therapeutic MAs have become one of the fastest growing areas in the management of benign and malignant hematologic condition. Advancement of recombinant technology allows development of partially or fully humanized new agents. Despite this, they still carry significant risk of immune and non-immune mediated adverse events. Most of the therapeutic monoclonal antibody related adverse events (MCAAE) The severity of reaction is variable, ranging from mild involvement of single organ to severe and life-threatening reactions requiring hospitalization or even resulting in death.
Even for mild infusion reactions, where re-initiation of infusion is possible, there is resultant delay in delivery of infusions, distress to patients, and additional utilization of health care resources.
Due to unpredictability of standard infusion reaction (SIR), efforts have been focused on premedication to decreasing the incidence and severity of infusion reaction. Most institutions have protocols using corticosteroid, acetaminophen and antihistamine as part of their premedication protocols. This has reduced but not eliminated standard infusion reactions. Most recently, mast cell stabilizers are being added to standard protocols to further reduce the incidence and severity of standard infusion reactions with variable anecdotal success without formal study. Of all the monoclonal antibodies, only Daratumumab has been evaluated using this strategy.
This study seeks to evaluate the efficacy of mast cell stabilizer Montelukast (SINGULAIR) 10 mg in decreasing the SIR in patients receiving therapeutic MAs either alone or as part of chemoimmunotherapy in hematologic condition. The MAs being studied includes: Blinatumomab (BLINCYTO, Amgen Inc.), Daratumumab (DARZALEX, Janssen Biotech, Inc.), Elotuzumab (EMPLICIT, Bristol-Myers Squibb Company), Gemtuzumab (MYLOTARG, Pfizer Inc.), Obinutuzumab (GAZYVA, Genentech USA, Inc.), and Rituximab (RITUXAN, Genentech US); The investigators postulate that 10 mg of Montelukast, when given in addition to standard premedication, will lead to decrease in incidence of MA associated SIR, shorter infusion time and decrease use of additional health care resources
Detailed description
Study design:
This is a Phase II single arm open label study evaluating 10 mg Montelukast given at least 2 hours prior to infusion of monoclonal antibody in addition to standard premedication. Monoclonal antibodies being evaluated include those commonly used to treat hematologic and oncologic malignancies like (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab).
Arms/Intervention; Study subjects will be given 10 mg of Montelukast to be orally self-administered at least 2 hours prior to beginning of chemotherapy section Standard premedication will be administered according to institution protocol
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Montelukast (Singulair) | Other | Drug: Montelukast 10 Mg Oral TabletMontelukast(Singulair) 10mg to be taken in addition to standard institutional premedication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be at least 18 years.
- Able to provide consent for study participation (English and Spanish).
- 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).
- Able to tolerate leukotriene antagonist including Montelukast.
- Able to tolerate oral intake.
Key exclusion criteria (11 listed)
- Patients undergoing treatment with above monoclonal antibodies for indications other than stated in above eligibility criteria.
- Patients who cannot provide informed consent in English or Spanish.
- Patients taking Montelukast or other leukotriene antagonists for other indications at the time of screening.
- Known allergic reactions to Montelukast or other leukotriene inhibitors.
- On monoclonal antibodies other than the ones being studied (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast 10 Mg Oral TabletAlso: SingulairMontelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment | Drug | Montelukast (Singulair) |
Primary outcome
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion
Time frame: Through study completion (average 6 months)
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
3 secondary outcomes
Average Infusion Duration of Each Cycle of the Monoclonal Antibody Infusion in the Study Subject
Time frame: Through study completion (average 6 months)
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)
Time frame: Through study completion (average 6 months)
Discontinuation Rate of Monoclonal Antibody Infusion Due to SIRs
Time frame: Through study completion (average 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incidence rate of Infusion reaction Tolerability of infusion reaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MOHAMMED BUKARI, MD principal investigator
UCSF - Fresno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Montelukast 10 Mg Oral Tablet in people with Infusion Reaction and Monoclonal Antibody, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Standard Infusion Reactions (SIR) at Cycle 1 and During Subsequent Cycles of Monoclonal Antibody Infusion (time frame: Through study completion (average 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.