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NCT04198623 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
A Phase 2 study of Monoclonal Antibody and Infusion Reaction, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04198623: Completed Phase 2 study of Monoclonal Antibody and Infusion Reaction, sponsored by University of California, San Francisco.
NCT04198623 is a Phase 2 study of Monoclonal Antibody and Infusion Reaction that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04198623, a Phase 2 study of Monoclonal Antibody and Infusion Reaction, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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. 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 in
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Montelukast 10 Mg Oral Tablet
Study Locations (1)
California
- Community Cancer Institute - Clovis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-03-20 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 2 |
What the finished NCT04198623 record still lists
NCT04198623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Monoclonal Antibody appearing as the primary indexed condition, and to 1 intervention - of which Montelukast 10 Mg Oral Tablet is the first listed.
NCT04198623 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04198623 about?
NCT04198623 is a clinical study titled "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 agen...
What is the current status of trial NCT04198623?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-03-20. Estimated completion is 2024-07-31.
What conditions does trial NCT04198623 study?
This clinical trial studies the following conditions: Monoclonal Antibody, Infusion Reaction.
What interventions are being tested in trial NCT04198623?
The interventions under investigation include: Montelukast 10 Mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04198623?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04198623 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04198623's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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