A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .

A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies . - A randomized comparative phase 2 study : Palonosetron single-dose vousus repeated-dose for prevention of nausea and vomiting induced by multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies .

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012295

Enrollment

Registered

2013-11-15

Start date

2013-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haematological malignancies

Interventions

Palonosetron (0.75mg) intravenously dose 30 min before chemotherapy initiation on day1 . Palonosetron is administered on day 1 in the single-dose group. Palonosetron (0.75mg) intravenously dose 30 mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 20=< 2. Haematological malignancies 3. Multiple-day high or moderate emetic risk chemotherapy in patients with haematological malignancies. 4. Sufficient function of important organs 5. ECOG Performance Status of 0 to 2 6. Expected more than 1 months survival 7. Acquisition of written informed consent

Exclusion criteria

Exclusion criteria: 1. Having complications (the intestinal tract paralysis, pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, renal insufficiency, liver failure, mental disease, cerebrovascular disorder, active stomach, duodenal ulcer) 2. History of the severe hypersensitivity 3. A pregnant woman, a nursing girl .the man or woman who does not agree preventing conception during a study period . 4. History of the dosage of palonosetron 5. Not to have ability to cooperate about the procedure of this study or intention toward 6. Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
CC (Complete Control) rate in overall phase ( 0-168 hours after chemotherapy ).	—

Secondary

Measure	Time frame
CR (Complete Response)rate in overall phase (0-168 hours after chemotherapy ) and safety.	—

Countries

Japan

Contacts

Public ContactTomonori Hidaka

Faculty of Medicine , University of Miyazaki Hospital Oncology unit

tmnhdk@med.miyazaki-u.ac.jp0985-85-9121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026