NCT01914484View on ClinicalTrials.gov

Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

August 1, 2013

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Chronic Phase Chronic Myeloid LeukemiaAccelerated Phase Chronic Myeloid LeukemiaBlastic Phase Chronic Myeloid LeukemiaPhiladelphia Positive Acute Lymphoblastic LeukemiaResistant to Tyrosine Kinase Inhibitor Therapy
Interventions
DRUG

Nilotinib

Nilotinib dose will remain fixed at 400mg bid throughout the cycles. BCR-ABL kinase inhibitor

DRUG

Ruxolitinib

"In the phase I part of the study, dose escalation will follow a 3+3 study design at either of 3 fixed dose levels (10 mg bid, 15 mg bid or 20 mg bid).~No intra-patient dose-escalation will occur. JAK inhibitor"

Trial Locations (1)

M5G 2M9

Princess Margaret Hospital / University Health Network, Toronto

Sponsors

Collaborators (1)

Novartis
All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

University Health Network, Toronto

OTHER