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Acute Myeloid Leukemia (AML)NCT01685619

AML-MDS Novel Prognostic Tests Clinical Study

An observational study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Nova Scotia Health Authority at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical study will provide the study specimens (samples of bone marrow and blood) and the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML Research Consortium. Read more about this study

Who is it for?
Ages 18 years and older
How many people
11 participants
Where
6 sitesCanada
Study dates
2 Oct 2012to 24 Jan 2018
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Prospective participants will include patients with known or supsected AML or MDS who are being treated and/or assessed at a participating site.

Who may be able to join

  • Prospective participants can be included in the study if:
  • The participant is 18 years of age or older
  • The participant is suspected to have a new diagnosis of MDS (including CMML) , OR suspected to have a new diagnosis of AML excluding acute promyelocytic leukemia (APL), OR known to have a diagnosis of MDS (including CMML) confirmed by bone marrow aspirate and biopsy no more than one year prior to the date of enrollment AND without commencement of definitive therapy prior to enrollment
  • The participant is scheduled to have a diagnostic or confirmatory bone marrow aspirate and biopsy at a participating site, or in the case of prospective participants with an established diagnosis of MDS (including CMML), must be able to undergo a bone marrow aspirate for the study at the participating site
  • The participant must be able to read and/or understand spoken English or French so that they will be eligible for Part Two of the study
  • The participant must be able to understand and sign the informed consent form applicable to their situation
Show all 22Show fewer
  • Participants who have been enrolled in Part One will be eligible to participate in the full two year study follow-up component if they meet the following criteria:
  • Confirmed diagnosis of either MDS, CMML or AML (excluding APL)
  • Sufficient cell count for the MDS/AML Clinical Study requirements as follows:
  • For participants with suspected (or known) AML:
  • The blast count of the peripheral blood taken at diagnosis must be greater than 1 x10^6 blast count/mL
  • It must be possible to earmark for the MDS/AML Study:
  • 3 vials 1.0 x 10^7/mL mononuclear peripheral blood cells
  • 1 vial 0.5 x 10^7/mL mononuclear bone marrow cells
  • Cells are to be prepared according to the site's local cell bank procedures so that they can be stored and transported to study labs as needed.
  • At sites participating in the Hogge Assay:
  • In addition to the specimens described above, it must be possible to provide 2 mL of fresh bone marrow or 5 mL of fresh peripheral blood with > 1 x 10^6 blast count/mL
  • For participants with suspected (or known) MDS:
  • It must be possible to earmark for the MDS/AML Study:
  • 2 vials 1.0 x 10^7/mL mononuclear peripheral blood cells
  • 2 vials 1.0 x 10^7/mL mononuclear bone marrow cells
  • Cells are to be prepared according to the site's local cell bank procedures so that they can be stored and transported to study labs as needed.

Who cannot join

  • Prospective participants should be excluded from the study if:
  • The participant has already received definitive therapy for AML or MDS
  • The participant has a diagnosis of MDS that was confirmed more than one year prior to the date of enrollment
  • Participants who have been enrolled in Part One will not be eligible to participate in the full two year study follow-up component if they:
  • Do not have sufficient cell count for the MDS/AML Clinical Study requirements as set out in Section 11.3
  • It is confirmed after enrollment that they do not have a diagnosis of MDS, CMML or AML
  • A diagnosis of APL is confirmed

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Princess Margaret Cancer Centre (formerly Princess Margaret Hospital)

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 4E3

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3M 1A5

Other trials in Canada

About this study

Official title: A Multi-Centre Observational Prospective Cohort Study Involving the Collection of Clinical Information and Biological Specimens for the Evaluation of Novel Prognostic Tests for Myelodysplasia and Acute Myeloid Leukemia

This clinical study will provide the study specimens (samples of bone marrow and blood) and the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML Research Consortium. The goal of this project involves the evaluation and potential validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid leukemia (AML), as well as an analysis of health economic and socio-ethical implications related to the potential introduction of these tests into the clinical setting. The over-arching goal is to improve the outcomes of patients with MDS and AML. The primary hypothesis is that one or more of the laboratory tests being evaluated in conjunction with this study, either alone or in combination with other laboratory tests (either established or under investigation in this project), will have statistically significant prognostic value either alone or in combination with established clinical risk factors.

The clinical study will involve the enrollment of 200 adults with AML and 200 adults with MDS over a 2.5 year period. Participants will be followed on study for two years. Bone marrow and blood specimens will be collected at diagnosis and at other time points as required for the development of the five laboratory tests.

Participants will be assigned to treatment according to local institutional practice and will be followed for up to 2 years. Health economic and quality of life questionnaires will be administered at key time points. Data will be collected regarding participant characteristics, diagnosis, disease features, treatment and clinical outcome.

Read the detailed description

Two of the tests involve a technology called flow cytometry. Both of the flow cytometry tests are used to predict whether a person is likely to have a good response to chemotherapy or not.

Three of the tests involve new genetic-based technology. One of these tests is called comparative genomic profiling. This test can detect genetic abnormalities that current testing methods are not able to detect. Another test involves micro-RNA profiling. The final test involves RNA sequencing. The researchers think these tests might be useful in predicting how well a person will respond to treatment.

The novel laboratory tests being evaluated as part of this study are still in the early phases of development and cannot be used for clinical decision making. Participants enrolled in this study will not be informed regarding their individual results with respect to the study tests that are conducted using their biospecimens.

The following information (data) will be collected regarding study participants: diagnosis, results of relevant clinical tests, age, gender, treatment and outcome during the 2 year study follow-up period. The study also involves the completion of study questionnaires at six different time points over the course of the two year study follow-up.

Keywords
AML, Acute Myeloid Leukemia, MDS, Myelodysplastic Syndrome, Prognostic, Economic
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01685619
Study groupRoleWhat they receive
AML CohortThis cohort is comprised of participants who have acute myelogenous leukemia (AML).
MDS CohortThis cohort is comprised of participants who have myelodysplastic syndrome (MDS).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognostic capacity of the candidate tests (alone and in combination) to predict response to treatment, time to relapse, time to death.

    For the AML cohort, the candidate prognostic tests will be analyzed with adjustments for following clinical factors: age, white blood cell count at presentation, antecedent hematologic disorder, FLT-3 status, Karnofsky Performance Status (KPS), cytogenetic sub-group (using WHO 2008). For the MDS cohort the candidate prognostic tests will be analyzed with adjustments for following clinical factors: age, KPS, karyotype, bone marrow blast count and number of cytopenias at diagnosis.

    Measured: Two years following the completion of enrollment.

Secondary outcomes (2)

  1. Cost impact of candidate tests.

    The cost-effectiveness of the candidate tests for AML and MDS treatment will be projected with the aid of economic simulation models.

    Measured: Two years following the completion of enrollment.

  2. Societal risks and benefits related to the candidate tests.

    A comparative analysis of policies and regulations in Canada governing prognostic tests will be undertaken (including tests that utilize RNA and DNA based technologies). In addition, input will be obtained from key stakeholders. This information will be used to develop a set of guidelines and best practices for this type of research.

    Measured: Two years following the completion of enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study start2 Oct 2012
  3. Primary completion24 Jan 2018
  4. Study completion24 Jan 2018

Resources

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
Prospective
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685619
Sponsor's protocol ID
AML-MDS 01-2011
Status last verified
Nov 2022
First submitted
12 Sep 2012
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by Nova Scotia Health Authority at 6 sites in Canada.

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 22 inclusion and 7 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. 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.

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?

Prognostic capacity of the candidate tests (alone and in combination) to predict response to treatment, time to relapse, time to death. (time frame: Two years following the completion of enrollment.). 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 NCT01685619.

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 8 Nov 2022.

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AML-MDS Novel Prognostic Tests Clinical Study | AzTrials