Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients
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
1 other identifier
interventional
105
1 country
15
Brief Summary
The objective is to treat elderly AML and MDS patients with sapacitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2007
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 23, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
June 4, 2024
CompletedJune 4, 2024
May 1, 2024
11 years
December 23, 2007
March 4, 2024
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Survival
Percentage of patients alive for one year measured from the date of randomization
up to 12 months from date of randomization
Secondary Outcomes (1)
CR and CRp
From date of randomization until study withdrawal or death assessed up to 6 months
Study Arms (9)
A sapacitabine
EXPERIMENTAL200 mg b.i.d. x 7 days every 3-4 weeks
B sapacitabine
EXPERIMENTAL300 mg b.i.d. x 7 days every 3 - 4 weeks
C sapacitabine
EXPERIMENTAL400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
D sapacitabine
EXPERIMENTAL200 mg b.i.d. x 7 consecutive days every 4 weeks
E sapacitabine
EXPERIMENTAL300 mg q.d. x 7 consecutive days every 4 weeks
F sapacitabine
EXPERIMENTAL300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
G sapacitabine
EXPERIMENTAL200 mg b.i.d. x 7 consecutive days every 4 weeks
H sapacitabine
EXPERIMENTAL300 mg q.d. x 7 consecutive days every 4 weeks
I sapacitabine
EXPERIMENTAL100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Interventions
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
200 mg b.i.d. x 7 consecutive days every 4 weeks
300 mg q.d. x 7 consecutive days every 4 weeks
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
200 mg b.i.d. x 7 consecutive days every 4 weeks
300 mg q.d. x 7 consecutive days every 4 weeks
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCLA Division of Hematology-Oncology
Los Angeles, California, 90095, United States
Stanford Hospitals and Clinics
Stanford, California, 94305, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institiute
Buffalo, New York, 14263, United States
New York Medical College
Hawthorne, New York, 10532, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt U Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Publications (1)
Kantarjian H, Faderl S, Garcia-Manero G, Luger S, Venugopal P, Maness L, Wetzler M, Coutre S, Stock W, Claxton D, Goldberg SL, Arellano M, Strickland SA, Seiter K, Schiller G, Jabbour E, Chiao J, Plunkett W. Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. Lancet Oncol. 2012 Nov;13(11):1096-104. doi: 10.1016/S1470-2045(12)70436-9. Epub 2012 Oct 15.
PMID: 23075701RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Julius, Huang, PhD.
- Organization
- Cyclacel Pharmaceuticals
Study Officials
- STUDY CHAIR
Hagop M Kantarjian, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2007
First Posted
January 10, 2008
Study Start
December 1, 2007
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
June 4, 2024
Results First Posted
June 4, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share