A Study of ORAL Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia


PHASE 3 Study | Identifier: NCT01303796

This study has completed enrollment

BACKGROUND: Sapacitabine is an oral nucleoside analogue that has been studied in elderly AML in Phase 1 and Phase 2 settings.
SEAMLESS Study: Estimated Enrollment: 485

  1. This is a multicenter, randomized, open label, Phase 3 study comparing two drug regimens (arms) as the front-line treatment of elderly patients age 70 years or older with newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has refused intensive treatment after being fully informed about its benefits and risks.
  2. The two drug regimens are oral sapacitabine administered in alternating cycles with IV decitabine or IV decitabine alone.
  3. IV decitabine cycles may be given at infusion centers near participating patients’ homes.
  4. In a phase 1/2 trial of patients that mirror the entry criteria of SEAMLESS the sapacitabine and decitabine regimen resulted in median overall survival of 231 days and an overall response rate (CR, CRp, PR or major hematological improvement) of 40%. Thirty-day mortality from all causes was 4% and sixty-day mortality from all causes was 12%. An additional 20% of patients stayed on study for 5 or more cycles with a decrease in bone marrow blast counts despite not meeting criteria of response. Approximately 60% of patients received 5 or more cycles of the regimen. No dose-limiting toxicities were observed in any patients. The median age in the group is 76 years (range 72-90). Nineteen patients are 75 years or older (76%). Common adverse events regardless of cause included anemia, asthenia, decreased appetite, diarrhea, constipation, dyspnea, limb edema, hypocalcemia, nausea, febrile neutropenia, neutropenia, lung infection, and thrombocytopenia, which were mostly moderate in intensity.
Trial Design Graph

Primary Outcome Measure

  • Overall survival

Secondary Outcome Measures

  • Complete remission with duration
  • Complete remission with incomplete platelet count recovery and duration
  • Partial remission with duration
  • Hematological improvement with duration
  • Stable disease with duration
  • 1-year survival
  • Number of units of blood product transfused
  • Hospitalized days

Key Inclusion Criteria

  • Newly diagnosed AML based on WHO 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 performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules

Key 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 other anti-cancer agents (except hydroxyurea and lenalidomide) for the preceding myelodyplastic syndrome (MDS) or myeloproliferative disorder (MPD)
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine

SEAMLESS Study Trial Site Locations

Contact: Judy H Chiao, MD


For complete information, visit A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS) at