A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

May 1, 2018

Primary Completion Date

November 6, 2022

Study Completion Date

May 16, 2023

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Vitamin C

All patients will receive at least 1 cycle of treatment (4 weeks) of Vitamin C as a continuous intravenous infusion (CIVI). Patients with clinical benefit (CR, PR, or SD) then will undergo a second 4-week cycle of treatment. Patients to receive a maximum of 16 weeks of treatment (4 cycles). If a patient progress after receiving a cycle of treatment then the patient will be withdrawn from the study. Patients will be maintained on 1 gram oral Vitamin C daily from the end of the CIVI until the beginning of the next cycle (from day 6 till 28).

Trial Locations (2)

10016

New York University School of Medicine, New York

33136

University of Miami Miller School of Medicine -Sylvester Cancer Center, Miami

All Listed Sponsors
collaborator

Perlmutter New York University Cancer Center

OTHER

lead

NYU Langone Health

OTHER

NCT03433781 - A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations | Biotech Hunter | Biotech Hunter