Acute Myeloid LeukemiaPhase 4LAMVIRENCT01819792
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
A Phase 4 study testing Multiplex respiratory viral PCR in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire, Amiens at 4 sites in France.
Trial summary
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Multiplex respiratory viral PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2013to Jul 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included.
- Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study
- Patients who have signed a consent policyholder
Who cannot join
- patients under 18 years old
- patients treated with another treatment than induction and consolidation chemotherapy
- pregnant women
- patients HIV, HBV or HBC positive
- patients with a positive PCR at J1
- patients treated with an antiviral treatment or an immunosuppressive treatment for another pathology
- patients under guardianship
- Primitive immunity Deficit
Trial locations and contacts
4 sites in 1 country.
France4 sites
Pr Marolleau
Amiens, 80054
CHU CAEN
Caen, 14000
Chru Lille
Lille, 59000
Chu Rouen
Rouen, 76000
About this study
Official title: Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
Read the detailed description
Bacterial and fungal infection treatment is well defined with guidelines. Few data are available for viral infections and concern essentially allogeneic stem cell transplantation. These infections are associated with a high mortality and morbidity rate. Data concerning AML are essentially retrospective, pediatric and with a little number of patients. Respiratory viral infections incidence is not known. These infections may be responsible for a higher mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia, co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral therapy. This study aims at understanding viral infections epidemiology during long term aplasia and optimizing their management.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Multiplex respiratory viral PCR
- Keywords
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex respiratory viral PCROther
| Study group | Role | What they receive |
|---|---|---|
| patient with Acute Myeloïd Leukemia | Other | Not described Receives: Other: Multiplex respiratory viral PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.
Measured: at day 15
Secondary outcomes (5)
seasonal viral infection incidence measure
Measured: 18 months after inclusion
risk factor of viral infections research
Measured: 18 months after inclusion
viral infections related morbidity and mortality estimation
Measured: 18 months after inclusion
bacterial and fungal co-infection estimation
Measured: 18 months after inclusion
description of antiviral therapeutic used for treating patients
Measured: 18 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre MAROLLEAU, MD PHD, Principal investigator, CHU AMIENSFABRICE JARDIN, MD PHD, Principal investigator, CHU ROUENOUMEDALY RENAN, MD PHD, Principal investigator, University Hospital, CaenBRUNO QUESNEL, MD PHD, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819792
- Sponsor's protocol ID
- PI2011_843_0005
- Acronym
- LAMVIRE
- Status last verified
- Apr 2018
- First submitted
- 18 Mar 2013
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
- ClinicalTrials.gov ID
- NCT01819792
- Acronym / sponsor ID
- LAMVIRE / PI2011_843_0005
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Mar 2013 (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.
Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.
Detailed description
Bacterial and fungal infection treatment is well defined with guidelines. Few data are available for viral infections and concern essentially allogeneic stem cell transplantation. These infections are associated with a high mortality and morbidity rate. Data concerning AML are essentially retrospective, pediatric and with a little number of patients. Respiratory viral infections incidence is not known. These infections may be responsible for a higher mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia, co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral therapy. This study aims at understanding viral infections epidemiology during long term aplasia and optimizing their management.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with Acute Myeloïd Leukemia | Other | Other: Multiplex respiratory viral PCR |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included.
- Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study
- Patients who have signed a consent policyholder
Key exclusion criteria (8 listed)
- patients under 18 years old
- patients treated with another treatment than induction and consolidation chemotherapy
- pregnant women
- patients HIV, HBV or HBC positive
- patients with a positive PCR at J1
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 |
|---|---|---|
| Multiplex respiratory viral PCR | Other | patient with Acute Myeloïd Leukemia |
Primary outcome
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
Time frame: at day 15
Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.
5 secondary outcomes
seasonal viral infection incidence measure
Time frame: 18 months after inclusion
risk factor of viral infections research
Time frame: 18 months after inclusion
viral infections related morbidity and mortality estimation
Time frame: 18 months after inclusion
bacterial and fungal co-infection estimation
Time frame: 18 months after inclusion
description of antiviral therapeutic used for treating patients
Time frame: 18 months after inclusion
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 23 Apr 2018.
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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.
Jean Pierre MAROLLEAU, MD PHD principal investigator
CHU AMIENS
FABRICE JARDIN, MD PHD principal investigator
CHU ROUEN
OUMEDALY RENAN, MD PHD principal investigator
University Hospital, Caen
4 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 Multiplex respiratory viral PCR in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire, Amiens at 4 sites in France.
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 3 inclusion and 8 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs (time frame: at day 15). 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 23 Apr 2018.