Volasertib and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The main purpose of this investigational research study is to determine how safe and
tolerable the study drug volasertib is in combination with liposomal vincristine (Marqibo; an
FDA-approved drug) in patients with relapsed/refractory acute lymphoblastic leukemia. While
VSLI demonstrated an overall response rate of 35% in Acute Lymphoblastic Leukemia (ALL)
patients that had failed to respond to or relapsed after chemotherapy, combining it with
other agents may increase clinical benefit.
Volasertib inhibits proteins involved in the cell cycle that are increased in ALL. When
volasertib inhibits these proteins ALL cells die. In the laboratory, volasertib has been
shown to increase activity of vincristine against ALL cells. Therefore, we think the
combination of volasertib and VSLI will be more effective against your leukemia than either
drug used alone. This study will try to find out what effects, good and/or bad, this drug
combination has on the patient and their cancer, and to find a dose that may be used in
future studies.
Phase:
Phase 1
Details
Lead Sponsor:
Northwestern University
Collaborators:
National Cancer Institute (NCI) National Comprehensive Cancer Network