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

Sponsor
Cyclacel Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00590187
Collaborator
(none)
408
Enrollment
15
Locations
9
Arms
132
Actual Duration (Months)
27.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Sapacitabine, Arm A
  • Drug: Sapacitabine, Arm B
  • Drug: Sapacitabine, Arm C
  • Drug: Sapacitabine, Arm D
  • Drug: sapacitabine, Arm E
  • Drug: sapacitabine, Arm F
  • Drug: Sapacitabine, Arm G
  • Drug: Sapacitabine, Arm H
  • Drug: Sapacitabine, Arm I
 Phase 2

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 Design

Study Type:
Interventional
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 :
Dec 1, 2007
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 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, 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survival [up to 24 months]

      Percentage of patients alive for one year measured from the date of randomization

    Secondary Outcome Measures

    1. CR and CRi [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 UCLA Division of Hematology-Oncology Los Angeles California United States 90095
    3 Stanford Hospitals and Clinics Stanford California United States 94305
    4 Winship Cancer Institute Atlanta Georgia United States 30322
    5 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    6 Rush University Medical Center Chicago Illinois United States 60612
    7 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    8 University of Nebraska Medical Center Omaha Nebraska United States 68198
    9 The Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601
    10 Roswell Park Cancer Institiute Buffalo New York United States 14263
    11 New York Medical College Hawthorne New York United States 10532
    12 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    13 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    14 Vanderbilt U Medical Center Nashville Tennessee United States 37232
    15 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cyclacel Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT00590187
    Other Study ID Numbers:
    • CYC682-06
    First Posted:
    Jan 10, 2008
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Sapacitabine

    Study Results

    No Results Posted as of Mar 29, 2022