RecruitingPhase 2NCT03999723

Combining Active and Passive DNA Hypomethylation

Combining Active and Passive DNA Hypomethylation: A Randomized, Placebo-Controlled Phase II Study of the Efficacy and Safety of Oral Vitamin C in Combination With Azacitidine in Patients With Higher-Risk MDS, CMML-2 or Low-Blast Count AML

Sponsor

Kirsten Grønbæk

Enrollment

196 participants

Start Date

Sep 11, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two different approaches to reducing abnormal DNA methylation (a chemical change that affects how genes are turned on and off) can improve outcomes for people with certain blood cancers, including myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and low-blast-count acute myeloid leukemia (AML). **You may be eligible if...** - You have been diagnosed with higher-risk MDS, CMML with 10–29% bone marrow blasts, or AML with 20–30% blasts - Your doctor has determined that azacitidine (a standard chemotherapy for these conditions) is an appropriate treatment for you - If you have therapy-related MDS, you have not received radiation or chemotherapy for at least 6 months **You may NOT be eligible if...** - You are eligible for and able to receive a stem cell transplant from a donor - You have previously been treated with a hypomethylating agent (such as azacitidine or decitabine) - You are receiving another active cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTVitamin 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_SUPPLEMENTPlacebo

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.