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Montelukast for Infusion Reactions
Phase 2
Recruiting
Led By MOHAMMED BUKARI, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 oral intake
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (average 6 months)
Awards & highlights
Study Summary
This trial is testing whether the addition of the drug montelukast to the standard premedication given before infusion of a monoclonal antibody will decrease the incidence of standard infusion reactions.
Who is the study for?
Adults with blood disorders or cancers starting treatment with specific monoclonal antibodies (like Blinatumomab, Daratumumab) can join this trial. They must be able to take pills, consent in English/Spanish, and do follow-ups. Excluded are those with severe liver issues, certain vasculitis, other trials' participation, pregnancy, uncontrolled mental illness, allergy to Montelukast or on similar drugs for other reasons.Check my eligibility
What is being tested?
The trial is testing if a pill called Montelukast can reduce reactions from infusion treatments used in hematologic conditions. It's added to standard premedication hoping it'll lower reaction rates and healthcare needs during therapy with monoclonal antibodies like Rituximab.See study design
What are the potential side effects?
Montelukast may cause side effects such as abdominal pain, headache and dizziness. In rare cases it could lead to mood changes or increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am starting treatment with specific monoclonal antibodies for my blood disorder or cancer.
Select...
I can eat and drink without assistance.
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I am at least 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (average 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (average 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The incidence rates of standard infusion reaction(SIR) at cycle 1 and during subsequent cycles of monoclonal antibody infusion in the study subjects
Secondary outcome measures
Average infusion duration of each cycle the monoclonal antibody infusion in the study subject
Discontinuation rate of monoclonal antibody infusion due to SIRs
Incidence rate of Grade 3 or more monoclonal antibody infusion with each cycle of infusion and through out the entire duration of infusion (up to 6 cycles or till discontinuation which ever comes first
Side effects data
From 2013 Phase 3 trial • 220 Patients • NCT018570635%
Protein urine present
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Montelukast (Singulair)Experimental Treatment1 Intervention
Montelukast(Singulair) 10mg to be taken in addition to standard institutional premedication
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,475 Total Patients Enrolled
MOHAMMED BUKARI, MDPrincipal InvestigatorUCSF - Fresno
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with eosinophilic vasculitis.I am currently taking Montelukast or similar medications.I can give my consent in English or Spanish.I am starting treatment with specific monoclonal antibodies for my blood disorder or cancer.I can eat and drink without assistance.I am being treated with specific antibodies for a condition not listed in the eligibility criteria.I have a history of severe depression or thoughts of harming myself.I cannot attend follow-up visits or answer calls.I am not on any monoclonal antibodies except for Blinatumomab, Daratumumab, Elotuzumab, Gemtuzumab, Obinutuzumab, or Rituximab.My liver function tests are significantly above normal limits.I can provide informed consent in English or Spanish.You have had allergic reactions to Montelukast or other medications called leukotriene inhibitors.I am at least 18 years old.I can take medications like Montelukast without severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Montelukast (Singulair)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what medical issues is this therapy typically applied?
"This course of treatment has been approved for the management of exercise-induced bronchospasm, perennial allergic rhinitis (PAR), and seasonal allergic rhinitis."
Answered by AI
Have regulatory authorities sanctioned this therapeutic approach?
"Taking into account the evidence collected thus far, our team at Power judged this treatment's safety to be a 2. This is due to the fact that only limited data exists in regards to its efficacy and more robust clinical results exist for security evaluation."
Answered by AI
Has there been any prior research conducted on this therapeutic approach?
"Currently, there are 22 active trials being conducted in relation to this treatment. 6 of these studies have reached Phase 3, with most taking place in Lexington, Kentucky. In total, 221 locations host clinical investigations regarding this medication's efficacy."
Answered by AI
What is the ceiling of participants for this research endeavor?
"Affirmative. Clinicaltrials.gov records confirm that this medical trial, first posted on March 20th 2020, is still enlisting participants. Approximately 80 patients must be acquired from a single site."
Answered by AI
Are there any openings available for enrolment into this clinical experiment?
"Affirmative, the information available on clinicaltrials.gov states that this investigation is currently recruiting participants. The trial was first introduced on 20 March 2020 and last modified 31 October 2022. 80 people are needed from 1 single site."
Answered by AI
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