NCT01211457

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Cyclacel Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	sapacitabine and decitabine (Part 1 - completed)	decitabine will be administered in alternating cycles with sapacitabine
DRUG	sapacitabine and venetoclax (Part 2 - recruiting)	sapacitabine will be administered concomitantly with venetoclax

Timeline

• Start date: 2010-06-17
• Primary completion: 2020-06-20
• Completion: 2020-12-31
• First posted: 2010-09-29
• Last updated: 2019-07-16

Locations

3 sites across 1 country: United States