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A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia — VIAC  

Leukemia, Myeloid, Acute Clinical Trial

Official title:
A Phase I Study of Volasertib Combined With Standard Induction Chemotherapy for Previously Untreated Patients With Acute Myeloid Leukemia (VIAC)

Clinical Trial Summary

This is a Phase I clinical trial to determine the maximum tolerated dose (MTD) of the polo-like kinase-1 inhibitor volasertib which can be safely combined with idarubicin plus cytarabine induction chemotherapy for previously untreated patients with acute myeloid leukemia. (AML).

Clinical Trial Description

Main inclusion criteria:

1. AML, any subtype except acute promyelocytic leukemia (APL)

2. At least one of the following features:

i. Age 18-75 with adverse risk cytogenetics ii. Age 18-75 with antecedent myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPD), or therapy-related AML iii. Age 60-75, regardless of risk category

3. No prior therapy for AML other than hydroxyurea

4. Judged by treating physician to be medically fit for induction chemotherapy

5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2

6. Normal left ventricular ejection fraction

Subjects will receive induction chemotherapy consisting of idarubicin 12 mg/m2 on Days 1-3 plus cytarabine 200 mg/m2 (age 18-59) or 100 mg/m2 (age 60-75) as a continuous IV infusion x 7 days. Volasertib will be administered on day 4 in a dose-escalation schedule, using a standard 3+3 dose escalation design, over 3 dose levels. Once the MTD has been determined, an additional dose expansion cohort will be accrued. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02527174
Study type Interventional
Source University of Alberta
Contact
Status Withdrawn
Phase Phase 1
Start date November 2016
Completion date September 2018
View Details
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