Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Name: Sapacitabine Type: Drug
Name: sapacitabine Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
Criteria: 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
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Amy Valdmanis - 205-975-9481
UCLA Division of Hematology-Oncology
Los Angeles, California, United States
Status: Recruiting
Contact: Rose Malone - 310-794-0242
Stanford Hospitals and Clinics
Stanford, California, United States
Status: Completed
Nowalk Hospital
Norwalk, Connecticut, United States
Status: Withdrawn
Winship Cancer Institute
Atlanta, Georgia, United States
Status: Recruiting
Contact: Christine Hergert - 404-778-1822
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Status: Recruiting
Contact: Mary Beth Riley - 312-695-1379
Rush University Medical Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Jodi Palonis - 312-942-3327
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Margaret Green, RN - 773-702-0267
University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Rose Solberg, RN - 402-559-4810
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Contact: Sora Limor - 201-336-8598
Roswell Park Cancer Institiute
Buffalo, New York, United States
Status: Recruiting
Contact: Laurie Forde, RN - 716-845-8360
New York Medical College
Hawthorne, New York, United States
Status: Recruiting
Contact: Muhammad Rasul - 914-594-4400
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Status: Recruiting
Contact: Tara Nisbet - 717-531-0003
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Melissa Potuzak - 215-662-7383
Vanderbilt U Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Violeta Vartic - 615-343-1467
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Patricia Boone, RN - 713-792-9191
Start Date
December 2007
Sponsors
Cyclacel Pharmaceuticals, Inc.
Source
Cyclacel Pharmaceuticals, Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page