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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01126892

CAMN107ACO01

Details and patient eligibility

About

A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Stratum 1:

1. Currently participating in Novartis study CAMN107A2109
2. Written signed and dated informed consent prior to any study procedures being performed

Stratum 2:

1. Male or female
2. > 18 years
3. ECOG 0,1,2
4. ASL/ALT <= 2.5 ULN or <= 5.0 ULN
5. Alcaline Phosfatase <= 2.5 ULN
6. Serum Bilirrubin <= 1.5 ULN
7. Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours
8. Serum Lipase <= 1.5 ULN

Exclusion criteria

Stratum 1 and stratum 2:

1. Reduction of the cardiac function
2. Use of Coumadin
3. Other severe medical concurrent conditions
4. Treatment with medications that prolonged the QT interval.
5. Mayor surgery 15 days before the inclusion in the protocol
6. Pregnant women or lactation

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Nilotinib

Experimental group

Treatment:

Drug: Nilotinib