Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 18, 2015

Primary Completion Date

March 6, 2018

Study Completion Date

April 3, 2018

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

Nilotinib

Nilotinib was supplied by Novartis as 150 mg and 200 mg hard gelatin capsules. Nilotinib was not dosed by weight or body surface area. Medication labels were in German and complied with the legal requirements of Germany. They included storage conditions for the drug but no information about the patient. The investigator emphasized compliance and instructed the patient to take nilotinib exactly as prescribed.

DRUG

Ruxolitinib

Ruxolitinib was supplied by Novartis as 5 mg, 15 mg, and 20 mg tablets. Medication labels were in German and complied with the legal requirements of Germany. They included storage conditions for the drug but no information about the patient. The investigator emphasized compliance and instructed the patient to take ruxolitinib exactly as prescribed.

Trial Locations (4)

13353

Novartis Investigative Site, Berlin

60590

Novartis Investigative Site, Frankfurt

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY