A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.

A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies. - A phase II study of palonosetron to prevent nausea and vomiting induced by chemotherapy in haematological malignancies.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010746

Enrollment

Registered

2013-06-01

Start date

2012-07-30

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: day1 0.75mg (i.v.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 20 years or older 2) diagnosed as haematological malignancies 3) Planed following chemotherapy CHOP R-CHOP ABVD Bendamustine R-Bendamustine 4) Adequate organ function 5) ECOG performance status of 0-2 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) With other severe diseases 2) No double cancer 3) Hypersensitivity for palonosetron 4) History of palonosetron use 5) History of receiving high emetic risk chemotherapy classified according to Antiemetic Guideline for Patients with Malignancies in Japan 6) With nausea and/or vomiting 7) Require continuous administration of systemic steroids 8) Not appropriate for the study at the physician's assessment

Design outcomes

Secondary

Measure	Time frame
Complete Response Rate in overall phase(0-120 hours after chemotherapy) The proportion of patients without nausea in overall, acute and delayed phase Complete Control Rate in acute phase(0-24 hours after chemotherapy) Complete Control Rate in delayed phase(25-120 hours after chemotherapy) Complete Response Rate in acute phase(0-24 hours after chemotherapy) Complete Response Rate in delayed phase(25-120 hours after chemotherapy) The proportion of patients without nausea in acute phase The proportion of patients without nausea in delayed phase	—

Measure

Time frame

Complete Response Rate in overall phase(0-120 hours after chemotherapy) The proportion of patients without nausea in overall, acute and delayed phase Complete Control Rate in acute phase(0-24 hours after chemotherapy) Complete Control Rate in delayed phase(25-120 hours after chemotherapy) Complete Response Rate in acute phase(0-24 hours after chemotherapy) Complete Response Rate in delayed phase(25-120 hours after chemotherapy) The proportion of patients without nausea in acute phase The proportion of patients without nausea in delayed phase

—

Primary

Measure	Time frame
Complete Control Rate in overall phase(0-120 hours after chemotherapy)	—

Countries

Japan

Contacts

Public ContactMayako Uchida

Kyushu University Hospital Department of Pharmacy

mayako49@pharm.med.kyushu-u.ac.jp0926425940

Outcome results

None listed

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