LeukemiaPhase 4AMENO-2NCT00415103
AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors
A Phase 4 study testing Aprepitant, Palonosetron and Granisetron in people with Leukemia and Lymphoma, run by PETHEMA Foundation at 5 sites in Spain.
Trial summary
The purpose of this trial is to determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Aprepitant, Palonosetron and Granisetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 5 sitesSpain
- Study dates
- Nov 2006to Sep 2009
- Phase
- Phase 4
- 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
- Patients 18 years old or up
- Will go through a Haematopoietic progenitors transplant (of mother cells from periphery blood or bone marrow with at least a 5 days long previous regime (with or without radiotherapy)
- women in fertile age must give negative in the pregnancy test in serum or in urine, sensible to 25 UI of β-hCG, in the visit before the study and accept to use a contraceptive double barrier method at least from the 14 previous days to the administration of the first dose of the study drug to the 14 following days after the last dose.
- Patient has a Karnofsky punctuation ≥60
- Patient has an life expectancy ≥1 month
- Patient is capable to read, understand and to complete the study questionnaires including the questions which require a visual analogy scale answer
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- Patient understands the study procedure and agrees to participate in it, giving his written consent.
- Patient is going through one of these previous regimens:
- CBV (ciclofosfamide, BCNU and VP-16)
- BEAM (BCNU, VP-16, araC, melphalan)
- Regimens with BUCY (Busulfan x 4 days and ciclofosfamide with or without other agents)
- CYTBI (ciclofosfamide plus total body irradiation with/without others agents)
Who cannot join
- Patients that are in one of these situations if, according to investigator's opinion, it prevents their participation in the study.
- Mental disability or emotional or psychiatric significant disorder
- Patient consumes any kind of drug, included marijuana, or the investigator determines that he has excessive alcohol consumption.
- Patient has any kind of infection (e.g. pneumonia) or any other uncontrolled disease (e.g. digestive obstruction) different to the process that, in the investigator's opinion, could mix the study's results or put the patient at risk if the drug is administrated.
- Patient has history of hypersensitivity to granisetron, palonosetron or aprepitant.
- Patient has received any non proven drug (investigation) in the last 4 weeks.
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- Patient has history or present history of cardiac conduction disorders specially QTC interval. Anti-arrhythmic use or electrolytic disorders capable of giving cardiac conduction disorders.
- Abnormal lab values
- AST >2.5 X superior limit of normality
- ALT >2.5 x superior limit of normality
- Bilirubin >1.5 x superior limit of normality
- Creatinine >1.5 x superior limit of normality
- Patients that in the 48 hours before day 1 of the study they have been treated with the following antiemetics:
- 5HT-3 antagonist (ondansetron, granisetron, dolasetron, or tropisetron)
- Fenotiacines
- Butyrophenones: (haloperidol or droperidol)
- Benzamides: metoclopramide or alizapride
- Domperidone
- Cannabinoids
- Patient who has started to receive treatment with benzodiazepines or with opioids in the first 48 hours before the day 1 of the study, except unique daily doses of triazolam, temazepam, lorazepam and midazolam. The continuation of the chronic treatment with benzodiazepins or with opioids is authorized as long as this treatment has been initiated at least 48 hours before day 1 of the study (considering that they can increase their levels.)
- Patient is taking or has taken in the 7 days before day 1 of the study the following substrates of the CYP3A4:
- Terfenadine
- Cisapride
- Astemizol
- Pimozide Or the following CYTP3A4 inhibitors
- clarithromycin : azithromycin, erythromicin aroxithromycin nd are allowed
- Ketoconazole or itraconazole (fluconazol is allowed)
- Patient is taking or has taken in the 30 days before day 1 of the study the following substrates of the CYP3A4:
- Barbiturics
- Rifampicin or rifabutin
- Carbamazepin or fenitoin. The administration of fenitoin as prophylaxis in regimens with busulfan of short duration is allowed in the following cases:
- This is a common regimen of conditioning in the transplant:
- The short time of treatment together -5 days maximum- and
- With the recommendation to monitorize the levels of fenitoin (keeping in mind that the mutual interaction between aprepitant and fenitoin can decrease the level of both.)
- Patient is taking or has taken in the 7 days before day 1 of the study, steroids (They can be administrated as a rescue antiemetic if it is indicated)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario Gregorio Marañón
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario la Princesa
Madrid
Hospital Clínico Universitario de Salamanca
Salamanca
Hospital Universitario Marqués de Valdecilla
Santander
About this study
Official title: AMENO-2: Fase IV Study, National, Multiple Centers, Competitive, Randomized, Double Blind, Controlled With Parallel Groups to Determinate the Security, Tolerability and Efficacy of Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors
The purpose of this trial is to determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant.
Read the detailed description
Patients with haematopoietic cancer (as leukaemia and lymphomas) that are treated with high doses of intense chemotherapy for the haematopoietic progenitors transplant experiment intense nausea and emesis related to this chemotherapy treatment.
The introduction of regimens with antagonist of 5HT3 receptors (ondansetron, tropisetron, granisetron) seems to have reduced the magnitude of the problem in the first 24 hours after the beginning of the chemotherapy. However, in spite of the use of these drugs, it is very frequency to observe intense nausea and emesis induced by chemotherapy especially in the latest period (after 24 h).
MASCC guides establish that It is not possible to give firm recommendations in the prevention of the NVIQ for these patients. Currently, the treatment of this problem in patients that go through a total body irradiation is made with antagonist of 5HT3 receptors with or without Dexamethasone.
There is neither recommendation regarding the antiemetic prophylaxis in chemotherapy treatments with high emetogenic power of several days duration. However, there is controversy about the use of high doses of steroids to avoid the latest emesis in transplant patients ( because of the high doses of steroids, Its continuous use during several days in this clinical situation and because of the possible worsening of the immunodeficiency inherent to the oncohematology illness/the previous chemotherapy treatment received by the patient). In patients that go trough a haematopoietic progenitor's transplant, many teams prefer to avoid the use of steroids. Main clinical guides do not offer firm recommendations regarding antiemetic prophylaxis protocols in the TPH and antagonists of 5-HT3 receptors are commonly used in practice.
AMENO-1 study demonstrated that the incidence of NVIQ is high even with an anti-5HT3 daily prevention (experimenting vomits or requiring rescue treatment for 81% of the TPH receptors), this significantly ameliorated their quality of life.
Currently, there are new drugs with new action mechanisms and a probable synergy between them that increase control of the NVIQ out of the transplant field. For that reason we have designed a study with the purpose of evaluating whether these new drugs ameliorate the control that we currently have of NVIQ (which is far from optimal).
To avoid differences in terms of posology regimes, granisetron will be used as the common treatment with one daily dose of 3mg/day. The new experimental regime that we propose includes two newly commercialized drugs with complementary and different mechanisms of action that have demonstrated their efficacy and their security in the very emetogenic chemotherapy administrated only one day: aprepitant and palonosetron.
- Being tested
- Aprepitant, Palonosetron, Granisetron
- Keywords
- Emesis, Nausea, leukemia, lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days
PalonosetronDrug
Palonosetrón: 0.25 mg iv every 48 hours, starting day 1
GranisetronDrug
Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days Palonosetrón: 0.25 mg iv every 48 horas starting day 1 Receives: Drug: Aprepitant; Drug: Palonosetron |
| 2 | Active comparator | Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment. Receives: Drug: Granisetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- López Javier, Dr, Study chair, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415103
- Sponsor's protocol ID
- 2006-00055-18
- Acronym
- AMENO-2
- Status last verified
- Sep 2009
- First submitted
- 21 Dec 2006
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosi 1993; Agura 1995; Okamoto 1996
MASCC Consensus Conference on Antihemetic Therapy, 2004)
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMENO-2: Fase IV Study, National, Multiple Centers, Competitive, Randomized, Double Blind, Controlled With Parallel Groups to Determinate the Security, Tolerability and Efficacy of Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors
- ClinicalTrials.gov ID
- NCT00415103
- Acronym / sponsor ID
- AMENO-2 / 2006-00055-18
- Keywords
- Emesis, Nausea, leukemia, lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Dec 2006 (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.
The purpose of this trial is to determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant.
Detailed description
Patients with haematopoietic cancer (as leukaemia and lymphomas) that are treated with high doses of intense chemotherapy for the haematopoietic progenitors transplant experiment intense nausea and emesis related to this chemotherapy treatment.
The introduction of regimens with antagonist of 5HT3 receptors (ondansetron, tropisetron, granisetron) seems to have reduced the magnitude of the problem in the first 24 hours after the beginning of the chemotherapy. However, in spite of the use of these drugs, it is very frequency to observe intense nausea and emesis induced by chemotherapy especially in the latest period (after 24 h).
MASCC guides establish that It is not possible to give firm recommendations in the prevention of the NVIQ for these patients. Currently, the treatment of this problem in patients that go through a total body irradiation is made with antagonist of 5HT3 receptors with or without Dexamethasone.
There is neither recommendation regarding the antiemetic prophylaxis in chemotherapy treatments with high emetogenic power of several days duration. However, there is controversy about the use of high doses of steroids to avoid the latest emesis in transplant patients ( because of the high doses of steroids, Its continuous use during several days in this clinical situation and because of the possible worsening of the immunodeficiency inherent to the oncohematology illness/the previous chemotherapy treatment received by the patient). In patients that go trough a haematopoietic progenitor's transplant, many teams prefer to avoid the use of steroids. Main clinical guides do not offer firm recommendations regarding antiemetic prophylaxis protocols in the TPH and antagonists of 5-HT3 receptors are commonly used in practice.
AMENO-1 study demonstrated that the incidence of NVIQ is high even with an anti-5HT3 daily prevention (experimenting vomits or requiring rescue treatment for 81% of the TPH receptors), this significantly ameliorated their quality of life.
Currently, there are new drugs with new action mechanisms and a probable synergy between them that increase control of the NVIQ out of the transplant field. For that reason we have designed a study with the purpose of evaluating whether these new drugs ameliorate the control that we currently have of NVIQ (which is far from optimal).
To avoid differences in terms of posology regimes, granisetron will be used as the common treatment with one daily dose of 3mg/day. The new experimental regime that we propose includes two newly commercialized drugs with complementary and different mechanisms of action that have demonstrated their efficacy and their security in the very emetogenic chemotherapy administrated only one day: aprepitant and palonosetron.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aprepitant, Drug: PalonosetronAprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days Palonosetrón: 0.25 mg iv every 48 horas starting day 1 |
| 2 | Active comparator | Drug: GranisetronGranisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients 18 years old or up
- Will go through a Haematopoietic progenitors transplant (of mother cells from periphery blood or bone marrow with at least a 5 days long previous regime (with or without radiotherapy)
- women in fertile age must give negative in the pregnancy test in serum or in urine, sensible to 25 UI of β-hCG, in the visit before the study and accept to use a contraceptive double barrier method at least from the 14 previous days to the administration of the first dose of the study drug to the 14 following days after the last dose.
- Patient has a Karnofsky punctuation ≥60
- Patient has an life expectancy ≥1 month
Key exclusion criteria (35 listed)
- Patients that are in one of these situations if, according to investigator's opinion, it prevents their participation in the study.
- Mental disability or emotional or psychiatric significant disorder
- Patient consumes any kind of drug, included marijuana, or the investigator determines that he has excessive alcohol consumption.
- Patient has any kind of infection (e.g. pneumonia) or any other uncontrolled disease (e.g. digestive obstruction) different to the process that, in the investigator's opinion, could mix the study's results or put the patient at risk if the drug is administrated.
- Patient has history of hypersensitivity to granisetron, palonosetron or aprepitant.
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 |
|---|---|---|
| AprepitantAprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days | Drug | 1 |
| PalonosetronPalonosetrón: 0.25 mg iv every 48 hours, starting day 1 | Drug | 1 |
| GranisetronGranisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment | Drug | 2 |
Primary outcome
Determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant
Time frame: 15 days
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 18 Sep 2009.
- BackgroundBosi 1993; Agura 1995; Okamoto 1996
- BackgroundMASCC Consensus Conference on Antihemetic Therapy, 2004)
- Spanish association of HaematologyLink provided by the sponsor.
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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.
López Javier, Dr study chair
Hospital Universitario Ramon y Cajal
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aprepitant, Palonosetron and Granisetron in people with Leukemia and Lymphoma, run by PETHEMA Foundation at 5 sites in Spain.
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 12 inclusion and 35 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00415103, which also lists 2 linked publications.
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 18 Sep 2009.