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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01126892
• Date of registration: 18/05/2010
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase ENACT
• Scientific title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
• Date of first enrolment: January 2009
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01126892
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Colombia, Venezuela

Contacts

• Name: Novartis Pharmaceuticlas
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Myeloid Leukemia

Intervention(s)

Drug: Nilotinib

Primary Outcome(s)

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. [Time Frame: between 6 and 12 months]

Secondary Outcome(s)

To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study [Time Frame: 24 months]

To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response [Time Frame: 24 months]

To follow loss of HR (after previous confirmed HR for AP and CHR for CP) [Time Frame: 3, 6 and 12 months]

Secondary ID(s)

CAMN107ACO01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors