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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

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

NCT ID

NCT00905593

First Posted

May 18, 2009

Last Updated

July 17, 2012

Sponsor

Novartis Pharmaceuticals

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

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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