Acute Myeloid LeukemiaLAM-MMRNCT02714790
Prognostic Role of Minimal Residual Disease in Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia and Minimal Residual Disease, run by A.O.U. Città della Salute e della Scienza.
Trial summary
Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2015
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with new diagnosis of acute myeloid leukemia treated with intensive chemotherapy
Who may be able to join
- Diagnosis of Acute Myeloid Leukemia
- Age > 18 years
- Intensive chemotherapy as first line curative treatment
- Observation period: March 2004 - September 2014
- Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline
- Written informed consent
Who cannot join
- Diagnosis of Acute Promyelocytic Leukemia
- Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline
- Patient ineligible to intensive chemotherapy
About this study
Official title: Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta
Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)
- Keywords
- Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual, Wilms Tumor
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Complete remission after chemotherapy
Measured: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy
Secondary outcomes (3)
Disease Free Survival
Date of relapse or date of remission status
Measured: +28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years)
Overall Survival
Time to last follow-up or death
Measured: Date of last follow-up for at least 1 year (up to 10 years) or Death
Cumulative Incidence of Relapse
CIR was calculated from the date of allo-HCT to the date of relapse or the date of the last follow-up, with death without relapse as a competing event.
Measured: Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesta Audisio, A.O.U. Città della Salute e della Scienza
- Investigators
- Ernesta Audisio, MD, Principal investigator, AO Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714790
- Sponsor's protocol ID
- LAM-MMR
- Acronym
- LAM-MMR
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: paper publication
Publications
Frairia C, Aydin S, Audisio E, Riera L, Aliberti S, Allione B, Busca A, D'Ardia S, Dellacasa CM, Demurtas A, Evangelista A, Ciccone G, Francia di Celle P, Nicolino B, Stacchini A, Marmont F, Vitolo U. Post-remissional and pre-transplant role of minimal residual disease detected by WT1 in acute myeloid leukemia: A retrospective cohort study. Leuk Res. 2017 Oct;61:10-17. doi: 10.1016/j.leukres.2017.08.008. Epub 2017 Aug 30.
PubMed 28846953
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Prognostico Della Malattia Minima Residua Nella Leucemia Mieloide Acuta
- ClinicalTrials.gov ID
- NCT02714790
- Acronym / sponsor ID
- LAM-MMR / LAM-MMR
- Keywords
- Acute Myeloid Leukemia, Minimal Residual Disease, Wilms Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Mar 2016 (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.
Study purpose is to assess the prognostic role of Minimal Residual Disease (defined as medullary expression of WT1 gene), performed at Baseline and during treatment according to clinical practice. MRD results will be relate to treatment outcome and survival analysis variables (Overall Survival, Disease Free Survival, Cumulative Incidence of Relapse)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with new diagnosis of acute myeloid leukemia treated with intensive chemotherapy
Key inclusion criteria (6 listed)
- Diagnosis of Acute Myeloid Leukemia
- Age > 18 years
- Intensive chemotherapy as first line curative treatment
- Observation period: March 2004 - September 2014
- Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry performed at baseline
Key exclusion criteria (3 listed)
- Diagnosis of Acute Promyelocytic Leukemia
- Bone marrow WT1 expression and Immunophenotyping by multi-parametric flow cytometry NOT performed at baseline
- Patient ineligible to intensive chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response
Time frame: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy
Complete remission after chemotherapy
3 secondary outcomes
Disease Free Survival
Time frame: +28 days after End of induction chemotherapy -Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy - +30 days after Allogeneic Transplant - Date of Relapse for at least 1 year (up to 10 years)
Overall Survival
Time frame: Date of last follow-up for at least 1 year (up to 10 years) or Death
Cumulative Incidence of Relapse
Time frame: Date of Allogeneic Transplant, Date of Relapse for at least 1 year (up to 10 years - assessed every 3 months), Date of last follow-up for at least 1 year (up to 10 years) or Death
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 Mar 2016.
- Derived from this study: PubMed 28846953Frairia C, Aydin S, Audisio E, Riera L, Aliberti S, Allione B, Busca A, D'Ardia S, Dellacasa CM, Demurtas A, Evangelista A, Ciccone G, Francia di Celle P, Nicolino B, Stacchini A, Marmont F, Vitolo U. Post-remissional and pre-transplant role of minimal residual disease detected by WT1 in acute myeloid leukemia: A retrospective cohort study. Leuk Res. 2017 Oct;61:10-17. doi: 10.1016/j.leukres.2017.08.008. Epub 2017 Aug 30.
- Individual participant dataSharing planned: Yes. paper publication
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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.
Ernesta Audisio, MD principal investigator
AO Città della Salute e della Scienza di Torino
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Minimal Residual Disease, run by A.O.U. Città della Salute e della Scienza.
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 6 inclusion and 3 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Response (time frame: +28 days after End of induction chemotherapy - Before Allogeneic Transplant, average of 3 to 6 months from beginning of therapy). 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 NCT02714790, which also lists 1 linked publication.
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 Mar 2016.