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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590187
• Other study ID #: CYC682-06
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: December 1, 2018

Study information

• Verified date: May 2024
• Source: Cyclacel Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Institute	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Roswell Park Cancer Institiute	Buffalo	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	New York Medical College	Hawthorne	New York
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	UCLA Division of Hematology-Oncology	Los Angeles	California
United States	Vanderbilt U Medical Center	Nashville	Tennessee
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Stanford Hospitals and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Cyclacel Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & 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 my — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Percentage of patients alive for one year measured from the date of randomization	up to 12 months from date of randomization
Secondary	CR and CRp	Complete remission and complete remission without blood count recovery, transfusion requirements, hospitalized days and safety	From date of randomization until study withdrawal or death assessed up to 6 months

External Links

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