NCT01220648

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

October 6, 2010

Last Update Submit

May 1, 2015

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemiainterferon alfanilotinibcombinationCMLPhiladelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP) after switch from previous CML treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Nilotinib in conjunction with low dose interferon alfa

EXPERIMENTAL
Drug: Nilotinib, interferon-alfa

Interventions

Nilotinib, interferon-alfaDRUG
Also known as: AMN107
Nilotinib in conjunction with low dose interferon alfa

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Related Publications (1)

  • Guilhot F, Roy L, Saulnier PJ, Guilhot J. Interferon in chronic myeloid leukaemia: past and future. Best Pract Res Clin Haematol. 2009 Sep;22(3):315-29. doi: 10.1016/j.beha.2009.10.005.

    PMID: 19959083BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinibInterferon-alpha

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 14, 2010

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

DE(1)