A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Public ClinicalTrials.gov record NCT03593915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2, Open-label Clinical Study to Determine Preliminary Safety and Efficacy of Alvocidib When Administered in Sequence After Decitabine or Azacitidine in Patients With MDS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS. Patients with IPSS-R intermediate and above MDS have an increased risk of developing AML and may be treated with the same chemotherapy regimens used in patients with AML. Eight Phase I or II clinical trials have been completed in patients with AML, totaling more than 400 patients with both relapsed/refractory or newly diagnosed AML. Preclinical studies have demonstrated that decitabine exposure increased the expression of NOXA, which is a specific antagonist of the survival factor MCL 1. Pharmacologic downregulation of MCL-1 via CDK 9 inhibition, as well as upregulation of the MCL-1 antagonist, NOXA, following decitabine exposure may result in enhanced antileukemic activity in MCL-1-dependent malignancies.
Study identification
- NCT ID
- NCT03593915
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Interventions
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 28, 2018
- Primary completion
- Aug 15, 2021
- Completion
- Aug 15, 2021
- Last update posted
- Nov 8, 2023
2018 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Johns Hopkins | Baltimore | Maryland | 21218 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| US Oncology - Texas Oncology - Austin Midtown | Austin | Texas | 78705 | — |
| US Oncology - Texas Oncology - Baylor University Medical Center | Dallas | Texas | 75246 | — |
| US Oncology - Texas Oncology - Fort Worth | Fort Worth | Texas | 76104 | — |
| US Oncology - Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | — |
| US Oncology - Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| US Oncology - Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| US Oncology - Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03593915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 8, 2023 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03593915 live on ClinicalTrials.gov.