Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:1/27/2019
Start Date:December 2007
End Date:December 1, 2018

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A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes

The main objective of this study is to learn which sapacitabine treatment is more likely to
keep the cancer in check for at least one year in AML patients who are at least 70 years of
age or older and in MDS patients who are at least 60 years of age.


Inclusion Criteria:

- A histologically or pathologically confirmed diagnosis of AML based on WHO
classification which is previously untreated by systemic therapy or is in first
relapse after achieving a complete remission to initial induction, consolidation
and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk
risk which has been previously treated with hypomethylating agents

- Age 70 years or older for AML and 60 years or older for MDS

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper
limit of normal (ULN)

- Adequate liver function defined as total bilirubin or direct bilirubin equal to or
less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5
x ULN (5 x ULN if tumor has affected the liver)

- Life expectancy reasonably adequate for evaluating the treatment effect

- Patient must be able to swallow capsules

- Patients must be at least 2 weeks from prior systemic therapy, radiation therapy,
major surgery, or other investigational therapy, and have recovered from clinically
significant toxicities of these prior treatments

- All men and women of reproductive potential must agree to practice effective
contraception for 4 weeks prior to study entry, during the entire study period and for
one month after the study unless documentation of infertility exists

- Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

- AML is of the sub-type of acute promyelocytic leukemia

- Having received more than one induction systemic therapy for AML or having received a
standard dose or high dose ara-C containing regimen for MDS

- Patients with known central nervous system (CNS) involvement by leukemia

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, active cancer(s) other than AML, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements. Patients receiving intravenous
antibiotics for infections that are under control may be included in this study

- Known to be HIV-positive
We found this trial at
15
sites
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Atlanta, Georgia 30322
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Buffalo, New York 14263
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, IL
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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...
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Hawthorne, New York 10532
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Los Angeles, California 90095
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Nashville, Tennessee 37232
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Stanford, California 94305
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