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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303796
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Sapacitabine Drug: Decitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Actual Study Start Date : October 1, 2011
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
Experimental: Sapacitabine-decitabine alternating
Arm A sapacitabine administered in alternating cycles with decitabine
Drug: Sapacitabine
oral sapacitabine capsules

Drug: Decitabine
decitabine intravenous

Active Comparator: Decitabine
Arm C Decitabine
Drug: Decitabine
decitabine intravenous

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 43 months ]

Secondary Outcome Measures :
  1. Complete remission with duration [ Time Frame: up to 43 months ]
    CR with duration

  2. Complete remission with incomplete platelet count recovery and duration [ Time Frame: up to 43 months ]
    CRp with duration

  3. Partial remission with duration [ Time Frame: up to 43 months ]
    PR with duration

  4. Hematological improvement with duration [ Time Frame: up to 43 months ]
    HI with duration

  5. Stable disease with duration [ Time Frame: up to 43 months ]
    SD with duration

  6. Number of units of blood product transfused [ Time Frame: up to 43 months ]
  7. Hospitalized days [ Time Frame: up to 43 months ]
  8. 1-year survival [ Time Frame: up to 43 months ]
    In %

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303796

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Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
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Study Chair: Hagop M Kantarjian, M.D. M.D. Anderson Cancer Center
Publications of Results:
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.

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Responsible Party: Cyclacel Pharmaceuticals, Inc. Identifier: NCT01303796    
Other Study ID Numbers: CYC682-12
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cyclacel Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors