Status:
UNKNOWN
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
Lead Sponsor:
Cyclacel Pharmaceuticals, Inc.
Collaborating Sponsors:
M.D. Anderson Cancer Center
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 previou...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
- Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
- ECOG performance status 0-2
- Adequate renal function
- Adequate liver function
- Able to swallow capsules
- Ability to understand and willingness to sign the informed consent form
Exclusion
- AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
- Known central nervous system (CNS) involvement by leukemia
- Uncontrolled intercurrent illness including
- Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
- Known to be HIV-positive
Key Trial Info
Start Date :
June 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01211457
Start Date
June 17 2010
End Date
December 31 2020
Last Update
July 16 2019
Active Locations (3)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030-3387