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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)

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ClinicalTrials.gov Identifier: NCT01303796
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 21, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date October 31, 2018
Actual Study Start Date  ICMJE October 1, 2011
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
Overall survival [ Time Frame: up to 43 months ]
OS
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
Overall survival [ Time Frame: up to 39 months ]
Change History Complete list of historical versions of study NCT01303796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Complete remission with duration [ Time Frame: up to 43 months ]
    CR with duration
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ]
    CRp with duration
  • Partial remission with duration [ Time Frame: up to 43 months ]
    PR with duration
  • Hematological improvement with duration [ Time Frame: up to 43 months ]
    HI with duration
  • Stable disease with duration [ Time Frame: up to 43 months ]
    SD with duration
  • Number of units of blood product transfused [ Time Frame: up to 43 months ]
  • Hospitalized days [ Time Frame: up to 43 months ]
  • 1-year survival [ Time Frame: up to 43 months ]
    In %
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Complete remission with duration [ Time Frame: Up to 39 months ]
  • Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 39 months ]
  • Partial remission with duration [ Time Frame: up to 39 months ]
  • Hematological improvement with duration [ Time Frame: up to 39 months ]
  • Stable disease with duration [ Time Frame: up to 39 months ]
  • Number of units of blood product transfused [ Time Frame: up to 39 months ]
  • Hospitalized days [ Time Frame: up to 39 months ]
  • 1-year survival [ Time Frame: up to 39 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title  ICMJE A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Brief Summary This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Detailed Description This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing two drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is administered in alternating cycles with decitabine, and in Arm C decitabine is administered alone. The primary efficacy endpoint is overall survival. The study is designed to demonstrate an improvement in overall survival of Arm A versus Arm C.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Sapacitabine
    oral sapacitabine capsules
  • Drug: Decitabine
    decitabine intravenous
Study Arms  ICMJE
  • Experimental: Sapacitabine-decitabine alternating
    Arm A sapacitabine administered in alternating cycles with decitabine
    Interventions:
    • Drug: Sapacitabine
    • Drug: Decitabine
  • Active Comparator: Decitabine
    Arm C Decitabine
    Intervention: Drug: Decitabine
Publications * Kantarjian, H.M.; Begna, K.H.; Altman, J.K.; Goldberg, S.L.; Sekeres, M.A.; Strickland, S.A.; Rubenstein, S.E.; Arellano, M.L.; Claxton, D.F.; Baer, M.R.; et al. Results of a Phase 3 Study of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Blood 2017, vol. 130 no. Suppl 1 891. http://www.bloodjournal.org/content/130/Suppl_1/891.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
482
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
470
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date December 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Newly diagnosed AML based on WHO (World Health Organization) classification
  • Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

  • AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for preceding myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Hungary,   Italy,   Poland,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303796
Other Study ID Numbers  ICMJE CYC682-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cyclacel Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cyclacel Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hagop M Kantarjian, M.D. M.D. Anderson Cancer Center
PRS Account Cyclacel Pharmaceuticals, Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP