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
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
| Drug | Synonyms | Arms |
|---|
| 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
| Name | Type | Description | Interventions |
|---|
| Sapacitabine/decitabine (Part 1 - completed) | Experimental | decitabine will be administered in alternating cycles with sapacitabine | - sapacitabine and decitabine (Part 1 - completed)
|
| sapacitabine/venetoclax (Part 2 - recruiting) | Experimental | sapacitabine 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: | Unknown status |
| Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
Trial Keywords
- Sapacitabine
- decitabine
- venetoclax
- elderly
- AML
- MDS
- Refractory
- relapsed
- untreated
Last Updated
July 16, 2019
