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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126892
• Other study ID #: CAMN107ACO01
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2010
• Last updated: February 24, 2017
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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
Colombia	Hospital San José, Bogotá, Colombia	Bogota
Venezuela	Banco Municipal de Sangre	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Colombia,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.		between 6 and 12 months
Secondary	To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response		24 months
Secondary	To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study		24 months
Secondary	To follow loss of HR (after previous confirmed HR for AP and CHR for CP)		3, 6 and 12 months

External Links

•   Results for CAMN107ACO01 from the Novartis Clinical Trials website