A Phase 2, Open-label, Randomized, Two-stage Clinical Study of Alvocidib in Patients with Relapsed/Refractory Acute Myeloid Leukemia Following Treatment with Venetoclax Combination Therapy
Sponsor: |
Tolero Pharmaceuticals, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS6739 |
U.S. Govt. ID: |
NCT03969420 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
You are being asked to take part in this study because you have acute myeloid leukemia (AML) that has come back after initial treatment (relapsed) with venetoclax combination therapy or because you did not get a complete response from your initial treatment (refractory) with venetoclax combination therapy. The purpose of this research study is to determine the effectiveness (how well something works) and safety of an investigational compound called alvocidib when used either in a combination treatment regimen (low-dose cytarabine) or as a single therapy (alvocidib alone). Investigational means that the Food and Drug Administration (FDA) has not yet approved this treatment as a prescription medicine; it is only available through research studies like this. Alvocidib was previously known as flavopiridol. Alvocidib is an investigational product being developed by Tolero Pharmaceuticals in AML. Cytarabine (also known as Ara-C) is one of the medicines considered as standard of care for the treatment of patients with AML.
This study is closed
Investigator
Daniel Lee, MD
Are you 18 years and older? |
Yes |
No |
Do you have confirmed diagnoses of Acute Myeloid Leukemia? |
Yes |
No |
Have you ever received Venetoclax in combination with azacytidine or decitabine? |
Yes |
No |