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Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (ENACT)

Primary Purpose

Chronic Myeloid Leukemia

Status
Approved for marketing
Phase
Locations
Mexico
Study Type
Expanded Access
Intervention
Nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Myeloid Leukemia focused on measuring chronic myeloid leukemia,, blast crisis,, accelerated phase,, nilotinib,, imatinib,, resistant,, intolerant,, chronic phase

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having participated in Novartis study CAMN107A2109, and
  • Written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

  • Impaired cardiac function,
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
  • Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
  • patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
  • Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
  • Patients unwilling or unable to comply with the protocol.

Other protocol -defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 18, 2009
Last Updated
July 17, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00905593
Brief Title
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Acronym
ENACT
Official Title
An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study Type
Expanded Access

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Approved for marketing
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on [CAMN107A2109] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
chronic myeloid leukemia,, blast crisis,, accelerated phase,, nilotinib,, imatinib,, resistant,, intolerant,, chronic phase

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nilotinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having participated in Novartis study CAMN107A2109, and Written signed and dated informed consent prior to any study procedures being performed. Exclusion Criteria: Impaired cardiac function, Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions, Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval, patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days, Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR Patients unwilling or unable to comply with the protocol. Other protocol -defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Guadalajara, Jalisco
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

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