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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-17

Study Completion Date

2020-12-31

Brief Summary

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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

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Detailed Description

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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

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Acute Myeloid Leukemia Myelodysplastic Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sapacitabine/decitabine (Part 1 - completed)

decitabine will be administered in alternating cycles with sapacitabine

Group Type EXPERIMENTAL

sapacitabine and decitabine (Part 1 - completed)

Intervention Type DRUG

decitabine will be administered in alternating cycles with sapacitabine

sapacitabine/venetoclax (Part 2 - recruiting)

sapacitabine will be administered concomitantly with venetoclax

Group Type EXPERIMENTAL

sapacitabine and venetoclax (Part 2 - recruiting)

Intervention Type DRUG

sapacitabine will be administered concomitantly with venetoclax

Interventions

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sapacitabine and decitabine (Part 1 - completed)

decitabine will be administered in alternating cycles with sapacitabine

Intervention Type DRUG

sapacitabine and venetoclax (Part 2 - recruiting)

sapacitabine will be administered concomitantly with venetoclax

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No