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A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes
This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS
This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rush University Medical Center
Chicago, Illinois, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Start Date
June 17, 2010
Primary Completion Date
June 20, 2020
Completion Date
December 31, 2020
Last Updated
July 16, 2019
65
ESTIMATED participants
sapacitabine and decitabine (Part 1 - completed)
DRUG
sapacitabine and venetoclax (Part 2 - recruiting)
DRUG
Lead Sponsor
Cyclacel Pharmaceuticals, Inc.
Collaborators
NCT06285890
NCT06220162
NCT04065399
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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