Combining Active and Passive DNA Hypomethylation

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.

Conditions

• Myelodysplastic Syndromes
• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia

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.

Sponsors & Collaborators

• Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team

  collaborator UNKNOWN

• Karolinska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Technical University of Denmark

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Kirsten Grønbæk

  lead OTHER

Principal Investigators

• Kirsten Grønbæk, Prof., MD · Rigshospitalet, Denmark

• Stine Ulrik Mikkelsen, MD, PhD · Rigshospitalet, Denmark

• Ali Al-Mousawi, MD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-11

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• Denmark
• Sweden

Study Locations