Study of Sapacitabine in Acute Myeloid Leukemia (AML)



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:70 - Any
Updated:11/2/2018
Start Date:June 2010
End Date:June 2020

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A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia

This is an open label, phase I/II study to evaluate the safety and efficacy of sapacitabine
administered in alternating cycles with decitabine in elderly patients with newly diagnosed
Acute Myeloid Leukemia (AML).


Inclusion Criteria:

- Newly diagnosed AML based on WHO classification

- 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

- 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 Criteria:

- AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor
without bone marrow involvement

- Having received any systemic anti-cancer therapy for AML or received treatment with
hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD

- Known central nervous system (CNS) involvement by leukemia

- Uncontrolled intercurrent illness including

- Known hypersensitivity to decitabine

- Known to be HIV-positive
We found this trial at
3
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
2181
mi
from 91732
Buffalo, NY
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
1726
mi
from 91732
Chicago, IL
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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