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

Phase 3

Completed

• Conditions: Chronic Myeloid Leukemia
• Interventions: Drug: Nilotinib

• Registration Number: NCT01126892
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-20
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response	24 months
To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study	24 months
To follow loss of HR (after previous confirmed HR for AP and CHR for CP)	3, 6 and 12 months

Trial Locations

Locations (2)

Banco Municipal de Sangre; 🇻🇪 Caracas, Venezuela

Hospital San José, Bogotá, Colombia; 🇨🇴 Bogota, Colombia