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

Novartis

Status

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Nilotinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00905593

CAMN107AMX01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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