ondansetron and Hematologic Malignancies

ondansetron has been researched along with Hematologic Malignancies in 8 studies

Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Research

Studies (8)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Total Number of Rescue Medications Needed -Delayed

"The total number of rescue medications needed for breakthrough chemotherapy-induced nausea and vomiting were calculated, starting from the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy.~The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for CINV prophylaxis." (NCT04535141)
Timeframe: Day 1 to 5 days after end of the chemotherapy ( Days 2-12).

Total Number of Rescue Medications Needed Acute

"The total number of rescue medications needed acute was calculated, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy.~The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for chemotherapy-induced nausea and vomiting (CINV) prophylaxis." (NCT04535141)
Timeframe: End of day 1 following last chemotherapy administration. (Up to day 2)

Frequency of Nausea in the Acute Phase

"Starting with the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy.~Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions. Scale: Never, Rarely, Occasionally, Frequently, Almost constantly.~To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed rarely in the first 24 hours following receipt of chemotherapy." (NCT04535141)
Timeframe: End of day 1 following last chemotherapy administration (Up to day 2)

Frequency of Somnolence

The frequency of somnolence was determined as the number of patients who experienced somnolence based on Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). The number of subjects has somnolence during the study period was counted. (NCT04535141)
Timeframe: Day 2-12

Number of Emesis Episodes in Delayed Phase

The number of emesis episodes in acute phase was defined as the number of subjects with no emesis, 1 emesis, and 2 or more emesis. (NCT04535141)
Timeframe: Day 1 to 5 days after end of the chemotherapy ( Days 2-12).

Number of Subjects Achieved Emesis Endpoint in Acute Phase.

: The number of subjects who did not experience emesis, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. Met endpoint = 0 emesis. (NCT04535141)
Timeframe: End of day 1 following last chemotherapy administration. (Up to day 2)

Number of Subjects Achieved Nausea Endpoint in the Delayed Phase.

"Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions, starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy.~Scale: Never, Rarely, Occasionally, Frequently, Almost constantly.~The number of subjects who experienced never or rarely nausea were considered as met the endpoint while those who experienced occasionally, frequently or almost constantly were considered as not met the endpoint." (NCT04535141)
Timeframe: Day 1 to 5 days after end of the chemotherapy (Days 2-12).

Number of Subjects Achieving Minimal Nausea

"To determine the number of subjects achieving minimal nausea was defined as the frequency of participants responded to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea question In the last 24 hours, how often did you have nausea? as rarely or less Starting with the first dose of chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy.~PRO-CTCAE of nausea scale includes categories: Never, Rarely, Occasionally, Frequently, Almost constantly To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed rarely and the score reported for the Pro-CTCAE question for nausea severity cannot exceed mild" (NCT04535141)
Timeframe: Day 2-12

Safety Endpoint: Qtc Prolongation

Prolongation of corrected QTc interval graded as defined in Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Corrected QTc was calculated using Fredericia's Formula. Corrected QT interval (QTc) = QT interval / (60/Heart rate)^0.33. (NCT04535141)
Timeframe: Day 1 to 5 days after end of the chemotherapy (Days 2- 12).

Severity of Nausea in Delayed Phase

"The severity of nausea in the delayed phase was defined as the response of the subject to the PRO- CTCAE nausea question.~Starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy (PRO-CTCAE) Scale: Never, Rarely, Occasionally, Frequently, Almost constantly~o meet the endpoint, the subject could not have answered a score as higher than mild in the period of time starting 24 hours after the last dose of chemotherapy and continuing until the 5th day following receipt of chemotherapy ." (NCT04535141)
Timeframe: Day 2-12

Overall Percentage of Patients Who Had a Complete Response

Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy. (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Participants With no Significant Nausea in Acute Phase

Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Participants With no Significant Nausea in Delayed Phase

Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Patients Achieving Complete Protection in Overall Assessment Phase

(CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after] (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Patients With Complete Response in Acute Phase

Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy) (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Patients With Complete Response in Delayed Phase

Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy) (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Patients With no Nausea in Overall Assessment Period

No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after) (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Percent of Patients With no Significant Nausea in Overall Assessment Period

Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm (NCT02635984)
Timeframe: Until study completion; estimated 1.5 years

Trials

7 trials available for ondansetron and Hematologic Malignancies

Other Studies

1 other study available for ondansetron and Hematologic Malignancies