Our Mission
About
- Our team
- Info
- David Wallace Bio
  David Wallace
  
  Founder & CEO of MPN Cancer Connection and PV Reporter | Patient Advocate
  When David was diagnosed with PV in 2009, at the age of 47, he soon learned there was limited and often conflicting information available on Myeloproliferative Neoplasms (MPNs). He also realized early on in his diagnosis, the importance of advocating for himself to best manage his polycythemia vera (PV). David was grateful for the early support and guidance of fellow MPN patients on his journey and wanted a way to give back to the MPN community. With a professional background in business administration and sociology, David has a passion for finding solutions and helping others. In 2013, David used his skill set to create PV Reporter, a comprehensive patient-focused website for MPNs. David refers to his site as a hub for patients to begin to research their cancer. Whether a patient, caregiver or healthcare provider, PV Reporter offers visitors a wealth of educational resources, patient stories, articles, and the latest news on the treatment for MPNs, helping MPN patients and their caregivers stay informed, connected and empowered. In 2015, along with the help of others, David founded a non-profit MPN Cancer Connection (MPN-CC), a patient-led 501©3 formed to create awareness that MPN patients are “cancer patients” and should have complete access to local and national programs and benefits. David’s philosophy is to educate patients to become their own advocates so that they can make informed decisions on their treatment. David’s dedication to the MPN community is further evidenced through his work and awards:
  - Selected to endorse 2018 NCCN guidelines for MPN patients by MPN Cancer Connection
  - Selected to represent the United States as a patient advocate by MPNs Advocate Network International Conference 2016-2019
  - Recipient of MPN Hero Award 2016
  - Published in MD Anderson Cancer Center MPN Focus Newsletter Fall 2016
  - Appearance on “The Doctors” TV show in 2015 to promote MPN awareness
  - Awarded Press Credentials for American Society of Hematology Conference 2014-2019
  - Contributor to Patient Power MPN educational videos
  David lives in Charlotte, North Carolina. When he’s not working, David enjoys spending time with family, listening to live music, attending outdoor festivals, watching the Carolina Panthers, riding his motorcycle, traveling and of course having his beloved Aussiedoodle Bailey by his side.
Resources
Our Vision
Donate
Blog
Contact

Clinical Trial Finder

Combining Active and Passive DNA Hypomethylation

Study Purpose

This is a multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in patients with higher-risk MDS, CMML-2 or low-blast count AML. The primary purpose is to investigate if oral vitamin C supplementation to azacitidine, compared with azacitidine + placebo, can increase the effectiveness of epigenetic therapy in patients with higher-risk myeloid malignancies, who are not candidates for allogeneic hematopoietic stem cell transplantation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

• Patients eligible for treatment with azacitidine with one of the following diagnoses according to World Health Organization 2016:

- MDS Higher-risk MDS according to the IPSS-R, i.e., intermediate- to very high-risk (IPSS-R score > 3) - CMML CMML with 10-29 percent marrow blasts without myeloproliferative disorder.

- AML AML with 20-30 percent blasts (low-blast count AML) Note: Patients with therapy-related MDS are eligible if they have not received radiation or chemotherapy for six months.

Exclusion Criteria:

- Patients eligible for allogeneic stem cell transplantation.

- Prior therapy with hypomethylating agents.

- Any matter constituting an exclusion criterion for treatment with azacitidine.

- Patients receiving other active cancer treatment, including investigational agents, with the exception of hydroxyurea for white blood cell control and granulocyte colony-stimulating factor.

- History of allergic reactions to ascorbic acid.

- History of kidney or urinary tract stones requiring intervention within the past year.

- Lack of ability to understand the information given, or lack of willingness to sign a written informed consent document.

- Unwillingness to comply with the protocol.

- Unwillingness to discontinue any and all use of vitamin C medication/supplementation including multivitamin at least 3 days (but preferably longer) prior to inclusion and baseline sampling.

- Planned azacitidine treatment after allogeneic stem cell transplantation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03999723
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Kirsten Grønbæk
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kirsten Grønbæk, Prof., MDStine Ulrik Mikkelsen, MDAnders P Vallentin, MD
Principal Investigator Affiliation	Rigshospitalet, DenmarkRigshospitalet, DenmarkRigshospitalet, Denmark
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia

Additional Details

EVI-3 is a phase 2 international, multicentre, randomized, parallel-group, placebo-controlled, double-blind study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine (AZA) in patients with higher-risk myeloid malignancies with or without mutations in genes recurrently affected in myeloid malignancies. Treatment allocation is in 1:1 ratio (vitamin C vs.#46; placebo) by block randomization stratified by clinical site. Study entry is staggered. Patients are randomized to either oral vitamin C 1000 mg daily or placebo from start of AZA treatment until end of study (EOS) or until AZA treatment is discontinued at the discretion of the treating physician, whichever occurs earlier. The accrual time is estimated to 48 months and 6 months follow-up, thus, maximum treatment duration will be approximately 54 months. A total of 196 patients is planned for enrollment. Study visits are scheduled at baseline, after 1st AZA treatment cycle, after 6 AZA treatment cycles, and, if AZA treatment is continued, at EOS or end of AZA treatment. Evaluations at study visits include bone marrow investigation, peripheral blood tests, patient-reported outcome measures, adverse events and compliance. Bone marrow aspirate and peripheral blood will be collected for biobank at each study visit. All patients will undergo follow-up once yearly from EOS. Follow-up will include information on duration of AZA therapy, survival and disease progression from myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) to acute myeloid leukemia (AML), if diagnosed following a clinical indication for a bone marrow test.

Arms & Interventions

Arms

Experimental: Vitamin C

Oral vitamin C (ascorbic acid) will be given in a dose of 1000 mg daily (two capsules of 500 mg once daily) starting day 1 in the 1st azacitidine (AZA) cycle (D1/C1) and continuing until discontinuation of AZA or end of study, whichever occurs earlier.

Placebo Comparator: Placebo

Placebo will be administered orally as two capsules once daily that look and taste identical to the capsules containing vitamin C. Treatment will start day 1 in the 1st azacitidine (AZA) cycle (D1/C1) and continuing until discontinuation of AZA or end of study, whichever occurs earlier. The content of the placebo capsules is glucose monohydrate, potato starch, gelatin, magnesium stearate and talc.

Interventions

Dietary Supplement: - Vitamin C

Oral vitamin C (ascorbic acid) 1000 mg daily will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS as combination treatment.

Dietary Supplement: - Placebo

Placebo capsules (two capsules once daily) will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.