Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

Phase 1

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: Nilotinib, interferon-alfa

• Registration Number: NCT01220648
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-14
• Study Start: 2012-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening
• Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow
• Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments
• Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment
• No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen

Exclusion Criteria

• Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases
• Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I)
• Impaired cardiac function
• Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib in conjunction with low dose interferon alfa	Nilotinib, interferon-alfa	-

Primary Outcome Measures

Name	Time	Method
Number of Clinically significant adverse events or abnormal laboratory values (dose-limiting toxicities) unrelated to disease progression, intercurrent illness, or concomitant medications on the combination treatment	12 months

Secondary Outcome Measures

Name	Time	Method
Event-free survival	12 months
Overall survival (OS)	12 months
Rate of major molecular response (MMR) at 12 months	12 months
Safety profile of nilotinib in combination with interferon alfa, i.e. the number of dose limiting toxicities (DLT) for each interferon alfa dose level	12 months
Progression-free survival (PFS)	12 months
Rate of major cytogenetic response (MCyR) at 6 and 12 months	12 months
Rate of complete cytogenetic response (CCyR) at 6 and 12 months	12 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Leipzig, Germany