Loading clinical trials...

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

NCT01018758•Gruppo Italiano Studio Linfomi

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, \>18 years of age;
•Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);
•Patients candidates to a initial chemotherapy treatment;
•ECOG performance status of 0-1;
•Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1;
•Written informed consent;
•Female of childbearing potential must be using reliable contraceptive measures;
•Acceptable hepatic and renal functions;
•Willing and able to complete the patient diary.

Exclusion Criteria

•Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide \>1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification);
•Diagnosis of Hodgkin's Disease or Leukemia;
•Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;
•Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;
•Have received any investigational drugs within 30 days before study entry;
•Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation);
•Prior treatment with Palonosetron;
•Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;
•Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;
•Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;
+5 more criteria

Locations (1)

Gruppo Italiano Studio Linfomi

Modena, Italy

Key Dates

Start Date

July 1, 2006

Completion Date

July 1, 2008

Last Updated

November 25, 2009

Enrollment

ACTUAL participants

Conditions

Chemotherapy-Induced Nausea and VomitingNon Hodgkin's Lymphoma

Interventions

Palonosetron

DRUG

Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

NCT05618925

Non Hodgkin's Lymphoma Refractory/Relapsed

View study

RECRUITINGPHASE1/PHASE2

TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL

NCT06014073

Non Hodgkin's Lymphoma

View study

RECRUITINGPHASE1/PHASE2

Chidamide Bridging for CAR-T Therapy

NCT05370547

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Inclusion Criteria

Exclusion Criteria

Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

TRAC and Power3 (SPPL3) Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL

Chidamide Bridging for CAR-T Therapy

A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC

A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL