Clinical Trials /

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

NCT01211457

Description:

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

Related Conditions:
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CYC682-11
  • NCT ID: NCT01211457

Conditions

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
sapacitabine and decitabine (Part 1 - completed)Sapacitabine/decitabine (Part 1 - completed)
sapacitabine and venetoclax (Part 2 - recruiting)sapacitabine/venetoclax (Part 2 - recruiting)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Sapacitabine/decitabine (Part 1 - completed)Experimentaldecitabine will be administered in alternating cycles with sapacitabine
  • sapacitabine and decitabine (Part 1 - completed)
sapacitabine/venetoclax (Part 2 - recruiting)Experimentalsapacitabine will be administered concomitantly with venetoclax
  • sapacitabine and venetoclax (Part 2 - recruiting)

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:response duration
Time Frame:2 years
Safety Issue:
Description:
Measure:transfusion requirements
Time Frame:2 years
Safety Issue:
Description:
Measure:hospitalized days
Time Frame:2 years
Safety Issue:
Description:
Measure:overall survival
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cyclacel Pharmaceuticals, Inc.

Trial Keywords

  • Sapacitabine
  • decitabine
  • venetoclax
  • elderly
  • AML
  • MDS
  • Refractory
  • relapsed
  • untreated

Last Updated

July 12, 2019