Spots Global Cancer Trial Database for Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

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Trial Identification

Brief Title: Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

Official Title: A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia or Myelodysplastic Syndromes

Study ID: NCT01211457

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Interventions

sapacitabine and decitabine (Part 1 - completed)

sapacitabine and venetoclax (Part 2 - recruiting)

Study Description

Brief Summary: This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

Detailed Description: This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.