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

Phase 2

Completed

Interventions: Drug: Sapacitabine, Arm A
Drug: Sapacitabine, Arm B
Drug: Sapacitabine, Arm C
Drug: Sapacitabine, Arm D
Drug: sapacitabine, Arm E
Drug: sapacitabine, Arm F
Drug: Sapacitabine, Arm G
Drug: Sapacitabine, Arm H
Drug: Sapacitabine, Arm I

Brief Summary: The objective is to treat elderly AML and MDS patients with sapacitabine.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A sapacitabine	Sapacitabine, Arm A	200 mg b.i.d. x 7 days every 3-4 weeks
B sapacitabine	Sapacitabine, Arm B	300 mg b.i.d. x 7 days every 3 - 4 weeks
C sapacitabine	Sapacitabine, Arm C	400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
D sapacitabine	Sapacitabine, Arm D	200 mg b.i.d. x 7 consecutive days every 4 weeks
E sapacitabine	sapacitabine, Arm E	300 mg q.d. x 7 consecutive days every 4 weeks
F sapacitabine	sapacitabine, Arm F	300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
G sapacitabine	Sapacitabine, Arm G	200 mg b.i.d. x 7 consecutive days every 4 weeks
H sapacitabine	Sapacitabine, Arm H	300 mg q.d. x 7 consecutive days every 4 weeks
I sapacitabine	Sapacitabine, Arm I	100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks

Primary Outcome Measures

Name	Time	Method
Survival	up to 12 months from date of randomization	Percentage of patients alive for one year measured from the date of randomization

Secondary Outcome Measures

Name	Time	Method
CR and CRp	From date of randomization until study withdrawal or death assessed up to 6 months	Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety

Locations (15): University of Chicago Cancer Research Center
🇺🇸
Chicago, Illinois, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Vanderbilt U Medical Center
🇺🇸
Nashville, Tennessee, United States
Roswell Park Cancer Institiute
🇺🇸
Buffalo, New York, United States
Northwestern University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
The Cancer Center at Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Winship Cancer Institute
🇺🇸
Atlanta, Georgia, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
UCLA Division of Hematology-Oncology
🇺🇸
Los Angeles, California, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Stanford Hospitals and Clinics
🇺🇸
Stanford, California, United States
New York Medical College
🇺🇸
Hawthorne, New York, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States