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

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

Inclusion Criteria

Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
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 (Part 1); age 18 years or older (Part 2)
ECOG performance status 0-2
Adequate renal function
Adequate liver function
Able to swallow capsules
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
Known central nervous system (CNS) involvement by leukemia
Uncontrolled intercurrent illness including
Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
Known to be HIV-positive

Additional locations may be listed on ClinicalTrials.gov for NCT01211457.

See trial information on ClinicalTrials.gov for a list of participating sites.

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.

Trial PhasePhase I/II

Trial Typetreatment

Lead OrganizationCyclacel Pharmaceuticals, Inc.

Primary IDCYC682-11
Secondary IDsNCI-2011-01175, CYC682-11(A1)
ClinicalTrials.gov IDNCT01211457

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

Inclusion Criteria

Exclusion Criteria

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

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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