Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions
Status:
Recruiting
Trial end date:
2022-09-20
Target enrollment:
Participant gender:
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 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