Hematological CC-486-AML-001

April 26, 2017

Sponsor: Celgene

Number: CC-486-AML-001

This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission. Complete remission) is usually defined as having no evidence of leukemia after treatment. This means the bone marrow contains fewer than 5% blast cells, the blood cell counts are within normal limits, and there are no signs or symptoms of the disease. Complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a hypomethylating agent will be excluded from the study.

Who’s eligible:

  • The patient must have newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia).
  • First Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
  • The Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, 2, 3. ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
  • This study is for patients age 55 and older.

Available at: The Hospital of Central Connecticut- The Cancer Center of Central Connecticut.

Cancer Clinical Research Office