Clinical trial · Interventional
A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT03441555CI-TRIAL-00056275completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvocidib | Drug | Alvocidib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax + Alvocidib
- description
- Venetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored.
- interventionNames
- Drug: Venetoclax
- Drug: Alvocidib
Primary outcomes (9)
- measure
- Tmax of venetoclax
- timeFrame
- Approximately 32 days after first dose of study drug
- description
- Time to maximum plasma concentration (Tmax) of venetoclax
- measure
- Clearance of Alvocidib
- timeFrame
- Approximately 32 days after first dose of study drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have adequate coagulation, hematology, kidney, and liver function, per protocol. * Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) * Meet the following disease activity criteria: * an established, confirmed diagnosis of AML by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3; and * an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * If male participant is sexually active, he must agree from day 1 through 6 months after the last dose of alvocidib or 90 days after the last dose of venetoclax, whichever is longer, to practice the protocol-specified protection. Exclusion Criteria: * History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ. * Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * History of previous enrollment in Studies NCT02993523 or NCT03069352. * History of exposure to alvocidib or any other cyclin-dependent kinase 9 (CDK9) inhibitor. * History of Tumor Lysis Syndrome (TLS) due to previous exposure to venetoclax.
References
Publications (0)
Data not yet available
No reference posted for this study.