L-Ascorbic Acid Depletion to Treat Acute Myeloid Leukemia and Myelodysplastic Syndromes
Manipulation of L-Ascorbic Acid Level For The Treatment of Selected Cases Of Acute Myeloid Leukemia and Myelodysplastic Syndromes
1 other identifier
interventional
25
1 country
1
Brief Summary
To document therapeutic gain achieved by cyclic application of L-ascorbic acid (LAA) supplementation and depletion, while confirming safety and avoidance of clinically significant scurvy, in chemorefractory patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 1998
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedOctober 26, 2006
October 1, 2006
May 22, 2006
October 25, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy
Safety, clinically
Secondary Outcomes (1)
Correlative studies between the modulation of the growth of leukemic colony-forming-cells(CFC) by L-ascorbic acid (LAA) in cell-culture and clinical response.
Interventions
Eligibility Criteria
You may qualify if:
- Patients should have AML or MDS according to new WHO classification, with minimum of 5% blasts in peripheral blood.
- There must be a clear and acceptable reason for not receiving standard treatments (chemotherapy and/or stem cell transplantation); or standard treatments have already been given and this option exhausted with evidence of refractory disease.
- Prior treatments of any forms are allowed provided there is no potential residual beneficial effect and the patients are off treatment for at least 4 weeks, with estimated life expectancy of at least 2 months.
- Adequate amount (4 ml) of bone marrow sent to the laboratory for cell culture studies.
- There are no restrictions based on age, sex, or ethnicity except that adequate contraception must be practiced in women of childbearing ages. Although AML is rare in children, pediatric patients will be accepted.
- There is no deficiency of G6PD (RBC).
- Asymptomatic patients with disease progression and symptomatic patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Jin Yang Pharmaceuticalcollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.
PMID: 19284416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Seog Kim, MD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
May 1, 1998
Study Completion
August 1, 2005
Last Updated
October 26, 2006
Record last verified: 2006-10