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Asthma drug may ease cancer treatment side effects

NCT ID NCT04198623

Symptom relief Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether montelukast (Singulair), a common asthma drug, can reduce the number and severity of infusion reactions in people receiving monoclonal antibody treatments for blood disorders. Forty adults were given montelukast along with standard premedication before their infusions. The goal was to see if this approach could make infusions safer, faster, and less stressful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Mar 2020

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients must be at least 18 years. 2. Able to provide consent for study participation (English and Spanish). 3. 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). 4. Able to tolerate leukotriene antagonist including Montelukast. 5. Able to tolerate oral intake. 6. Available for follow up by phone and on site. Exclusion Criteria: 1. Patients undergoing treatment with above monoclonal antibodies for indications other than stated in above eligibility criteria. 2. Patients who cannot provide informed consent in English or Spanish. 3. Patients taking Montelukast or other leukotriene antagonists for other indications at the time of screening. 4. Known allergic reactions to Montelukast or other leukotriene inhibitors. 5. On monoclonal antibodies other than the ones being studied (Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, and Rituximab). 6. History of uncontrolled depression or suicidal ideation or psychiatric illness. 7. Known Severe Hepatic Impairment (AST\>10x ULN; ALT\>10x ULN; ALP\>10x ULN; and/or Bilirubin \>5x ULN). 8. Patient with eosinophilic vasculitis. 9. Unable to comply with phone or in person follow-up. 10. Patients participating in another clinical trial. 11. Pregnancy

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Conditions

The condition(s) this trial relates to.

hematologic disorder hematopoietic and lymphoid cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infusion reaction Monoclonal antibody

Contacts and locations

Locations

  • Community Cancer Institute

    Clovis, California, 93611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.