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

March 23, 2022 updated by: Cyclacel Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Division of Hematology-Oncology
      • Stanford, California, United States, 94305
        • Stanford Hospitals and Clinics
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center at Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institiute
      • Hawthorne, New York, United States, 10532
        • New York Medical College
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt U Medical Center
    • Texas
      • Houston, Texas, United States, 77030-4009
        • The University of Texas Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A sapacitabine
200 mg b.i.d. x 7 days every 3-4 weeks
Drug: Sapacitabine, Arm A
200 mg b.i.d. x 7 days every 3-4 weeks
Other Names:
  • CYC682
Experimental: B sapacitabine
300 mg b.i.d. x 7 days every 3 - 4 weeks
Drug: Sapacitabine, Arm B
300 mg b.i.d. x 7 days every 3 - 4 weeks
Other Names:
  • CYC682
Experimental: C sapacitabine
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Drug: Sapacitabine, Arm C
400 mg b.i.d. x 3 days/week x 2 weeks every 3 - 4 weeks
Other Names:
  • CYC682
Experimental: D sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
Drug: Sapacitabine, Arm D
200 mg b.i.d. x 7 consecutive days every 4 weeks
Other Names:
  • CYC682
Experimental: E sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
Drug: sapacitabine, Arm E
300 mg q.d. x 7 consecutive days every 4 weeks
Other Names:
  • CYC682
Experimental: F sapacitabine
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Drug: sapacitabine, Arm F
300 mg b.i.d. x 3 consecutive days per week for 2 weeks every 4 weeks
Other Names:
  • CYC682
Experimental: G sapacitabine
200 mg b.i.d. x 7 consecutive days every 4 weeks
Drug: Sapacitabine, Arm G
200 mg b.i.d. x 7 consecutive days every 4 weeks
Other Names:
  • CYC682
Experimental: H sapacitabine
300 mg q.d. x 7 consecutive days every 4 weeks
Drug: Sapacitabine, Arm H
300 mg q.d. x 7 consecutive days every 4 weeks
Other Names:
  • CYC682
Experimental: I sapacitabine
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Drug: Sapacitabine, Arm I
100 mg q.d. x 5 consecutive days per week for 2 weeks every 4 weeks
Other Names:
  • CYC682

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: up to 24 months
Percentage of patients alive for one year measured from the date of randomization
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR and CRi
Time Frame: From date of randomization until study withdrawal or death assessed up to 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyclacel Pharmaceuticals, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2007

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

December 23, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYC682-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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