NCT03298984

Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).

A Phase 1, Open-label, Dose-escalation, Safety and Biomarker Prediction of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase I study is to determine the safety and tolerability including the maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML

Detailed description

Primary Objective: • To determine the safety and tolerability including the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML Secondary Objectives: * To observe patients for any evidence of antileukemic activity of alvocidib plus 7+3 using the 2017 ELN response criteria * To establish the Recommended Phase 2 Dose (RP2D) for future studies with alvocidib in combination with 7+3 Exploratory Objective: • To assess levels of minimal residual disease (MRD) using standardized techniques (ie, multiparametric flow cytometry \[MPFC\] and next generation sequencing \[NGS\] and evaluate other potential biomarkers including, but not limited to, MCL-1 dependency.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Alvocidib	IV bolus followed by IV infusion
DRUG	Cytarabine	continuous infusion
DRUG	Daunorubicin	IV bolus

Timeline

• Start date: 2017-09-25
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2017-10-02
• Last updated: 2023-11-15
• Results posted: 2021-05-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study