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

Chronic Myeloid Leukemia Clinical Trial

— 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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00905593
• Other study ID #: CAMN107AMX01
• Status: Approved for marketing
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: July 17, 2012
• Start date: September 2008

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Blast Crisis
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Nilotinib

Locations

Country	Name	City	State
Mexico	Novartis Investigative Site	Guadalajara, Jalisco
Mexico	Novartis Investigative Site	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Mexico,