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

• ClinicalTrials.gov Identifier: NCT00590187
• Recruitment Status: Completed
• First Posted: January 10, 2008
• Last Update Posted: January 25, 2019
• Sponsor: Cyclacel Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Cyclacel Pharmaceuticals, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia	Drug: sapacitabine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 408 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: December 2007
• Actual Primary Completion Date: December 1, 2018
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Survival [ Time Frame: one year ]

Secondary Outcome Measures :

1. Rate and duration of complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety [ Time Frame: during study ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, California

UCLA Division of Hematology-Oncology

Los Angeles, California, United States, 90095

Stanford Hospitals and Clinics

Stanford, California, United States, 94305

United States, Georgia

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of Chicago Cancer Research Center

Chicago, Illinois, United States, 60637

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

United States, New Jersey

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

United States, New York

Roswell Park Cancer Institiute

Buffalo, New York, United States, 14263

New York Medical College

Hawthorne, New York, United States, 10532

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

Vanderbilt U Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

Cyclacel Pharmaceuticals, Inc.

Investigators

• Study Chair: Hagop M Kantarjian, MD; M.D. Anderson Cancer Center

More Information

Additional Information:

Oral sapacitabine for the treatment of acute myeloid leukaemia in elderly patients: a randomised phase 2 study. 

Publications of Results:

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.

• Responsible Party: Cyclacel Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00590187
• Other Study ID Numbers: CYC682-06
• First Posted: January 10, 2008
• Last Update Posted: January 25, 2019
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasms by Histologic Type; Neoplasms; Sapacitabine; Antineoplastic Agents