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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

Phase 2
60 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

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

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

- Known to be HIV-positive

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Judy H. Chiao, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Cyclacel Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



University of Chicago Cancer Research Center Chicago, Illinois  60637
New York Medical College Valhalla, New York  10595
Rush University Medical Center Chicago, Illinois  60612-3824
Winship Cancer Institute Atlanta, Georgia  30322
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104
Northwestern University Feinberg School of Medicine Chicago, Illinois  60611
The Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Stanford Hospitals and Clinics Stanford, California  94305
UCLA Division of Hematology-Oncology Los Angeles, California  90095
Nowalk Hospital Norwalk, Connecticut  06856
Roswell Park Cancer Institiute Buffalo, New York  14263
Vanderbilt U Medical Center Nashville, Tennessee  37232