Chemotherapy-Induced Nausea and VomitingPhase 2NHLPalNCT01018758
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
A Phase 2 study testing Palonosetron in people with Chemotherapy-Induced Nausea and Vomiting and Non Hodgkin's Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma
- What is being tested?
- Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2006to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Female of childbearing potential must be using reliable contraceptive measures;
- Acceptable hepatic and renal functions;
- Willing and able to complete the patient diary.
Who cannot join
- 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);
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- 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;
- Clinically relevant electrolyte abnormalities;
- Have a known hypersensitivity to 5HT3 receptor antagonists;
- Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;
- Female patients who are pregnant or breast feeding;
- Inability to understand or cooperate with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
- Being tested
- Palonosetron
- Keywords
- Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy
- Medical subject headings
- Vomiting, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| palonosetron | Experimental | Not described Receives: Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
Measured: 0-120 hours
Secondary outcomes (6)
rate of Complete Response
Measured: within the first 24 h after chemotherapy and 24-120 h
number of emetic episodes
Measured: within the first 24 h after chemotherapy and 24-120 h
presence of nausea graded according to Likert scale
Measured: within the first 24 h after chemotherapy and 24-120 h
time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Measured: within the first 24 h after chemotherapy and 24-120 h
patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)
Measured: within the first 24 h after chemotherapy and 24-120 h
toxic effects of Palonosetron
Measured: within the first 24 h after chemotherapy and 24-120 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJul 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Investigators
- Nicola Di Renzo, MD, Principal investigator, Gruppo Italiano Studio Linfomi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018758
- Sponsor's protocol ID
- NHLPal
- Acronym
- NHLPal
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01018758
- Acronym / sponsor ID
- NHLPal / NHLPal
- Keywords
- Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| palonosetron | Experimental | Drug: Palonosetron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalonosetronPalonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy. | Drug | palonosetron |
Primary outcome
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
Time frame: 0-120 hours
6 secondary outcomes
rate of Complete Response
Time frame: within the first 24 h after chemotherapy and 24-120 h
number of emetic episodes
Time frame: within the first 24 h after chemotherapy and 24-120 h
presence of nausea graded according to Likert scale
Time frame: within the first 24 h after chemotherapy and 24-120 h
time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Time frame: within the first 24 h after chemotherapy and 24-120 h
patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)
Time frame: within the first 24 h after chemotherapy and 24-120 h
toxic effects of Palonosetron
Time frame: within the first 24 h after chemotherapy and 24-120 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Di Renzo, MD principal investigator
Gruppo Italiano Studio Linfomi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palonosetron in people with Chemotherapy-Induced Nausea and Vomiting and Non Hodgkin's Lymphoma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) (time frame: 0-120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.