Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
Sapacitabine, decitabine, venetoclax, elderly, AML, MDS, Refractory, relapsed, untreated
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.
Interventions
DRUGsapacitabine and decitabine (Part 1 - completed)
decitabine will be administered in alternating cycles with sapacitabine
DRUGsapacitabine and venetoclax (Part 2 - recruiting)
sapacitabine will be administered concomitantly with venetoclax
Sponsors
M.D. Anderson Cancer Center
Cyclacel Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| response duration | 2 years |
| transfusion requirements | 2 years |
| hospitalized days | 2 years |
| overall survival | 2 years |
Countries
United States
Contacts
Primary ContactJudy H Chiao, MD
Outcome results
None listed