Inclusion Criteria

There are two parts to the study: Part One (Collection of Biospecimens) and Part Two (Two
year follow-up that includes data collection regarding treatment, outcome and
questionnaire completion).

INCLUSION CRITERIA (PART ONE):

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

EXCLUSION CRITERIA (PART ONE):

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

INCLUSION CRITERIA (PART TWO):

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.

EXCLUSION CRITERIA (PART TWO):

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