Clinical trial: NCT03397173
Section: Alternatives
Subsections: What Are My Other Choices If I Do Not Take Part In This Study?

If you decide not to take part in this study, you have other choices. For example:  
- you may choose to have the usual approach described above
◾ you may choose to take part in a different study, if one is available
- or you may choose not to be treated for cancer. For example: comfort/palliative care
Clinical trial: NCT03397173
Section: Duration of Study Involvement
Subsections: How Long Will I Be In This Study?

The treatment will be continued up to 6 cycles depending upon toxicities. If there is no response to treatment by 6 months, you will be taken off the study. If you respond to the treatment, you may continue as long as you are responding and you do not have any side effects that prevent you from continuing the treatment. After you finish your treatment, your doctor will continue to watch you for side effects and follow your condition for 1 year (12 months) after your end of treatment visit.
Clinical trial: NCT03397173
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Common, Some May Be Serious In 100 People Receiving Ascorbic Acid More Than 20 And Up To 100 May Have:|Occasional, Some May Be Serious In 100 People Receiving Ascorbic Acid From 4 To 20 May Have:

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| Fatigue              |                       |
|----------------------|-----------------------|
| .                    |                       |
| .                    | Headache              |
| .                    | Nausea                |
| .                    | Vomiting              |
| .                    | Diarrhea              |
| .                    | Constipation          |
| .                    | Loss of appetite      |
| .                    | Bruising              |
| .                    | Low blood cell counts |
| .                    | Weakness              |
| .                    | Joint pain            |
| .                    | Shivering             |
| .                    | Cough                 |
| Difficulty Breathing |                       |
| .                    |                       |

| In 100 people receiving ascorbic acid from 4 to 20 may have:   |                                     |
|----------------------------------------------------------------|-------------------------------------|
| Pale skin                                                      |                                     |
| .                                                              |                                     |
| .                                                              | Swelling (such as in arms and legs) |
| .                                                              | Abnormal heart sound                |
| .                                                              | Fast heart beat                     |
| .                                                              | Low blood pressure                  |
| .                                                              | High blood pressure                 |
| .                                                              | Fainting                            |
| .                                                              | Dizziness                           |
| .                                                              | Anxiety                             |
| .                                                              | Depression                          |
| .                                                              | Lack of energy                      |
| .                                                              | Numbness                            |
| .                                                              | Pain                                |
| .                                                              | Skin hives and /or rash             |
| .                                                              | Dry skin and /or itching            |
| .                                                              | Sweating                            |  
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Clinical trial: NCT03397173
Section: Procedures
Subsections: What Extra Tests And Procedures Will I Have If I Take Part In This Study?|During The Study The Following Will Be Additional Research Procedures:

Most of the exams, tests, and procedures you will have are part of the usual approach for your blood condition. However, there may be some extra procedures/tests that you will need to have if you take part in this study. Biomarkers: At specified time points (Screening and Cycle 6 Day 14), blood and marrow samples will be collected to see whether the study drug is producing changes to the genes and proteins related to your cancer.  These samples will be used for this research as well stored for future research. Methylation Profile: At specific time points (Cycle 1) a sample from your blood will be taken to evaluate the methylation profile of your cancer cells. This profile will help the researchers to understand how the changes in this profile will affect your response to the treatment.

- Methylation profile (Cycle 1 only)
- Mutational Analysis (Cycle 6 Day 28)  
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Clinical trial: NCT03397173
Section: Purpose of Research
Subsections: Why Is This Study Being Done?

The purpose of this study is to evaluate the efficacy of treatment with Azacitidine (an FDA
approved drug for the treatment of various hematologic malignancies to include MDS, AML,
and certain types of MPN) and high dose ascorbic acid in patients with TET2 mutations. This approach is intended to enhance the enzymatic activity of TET2 protein, which in turn may help to improve your counts and symptoms, related to your disease. This combination is specific to individuals who carry this mutation.
Clinical trial: NCT03397173
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary. Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise
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any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may have.  A copy of this consent form will be provided to you.  
  
  
  
  
I have discussed the information contained in this document with the participant and it is my opinion that the participant understands the risks, benefits, alternatives and procedures involved with this research study.  
Signature of Person Obtaining Consent  
  
  
| Date   |
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