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

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Advanced Disease,, Resistance,, Intolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital San José, Bogotá, Colombia
  • Banco Municipal de Sangre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

Outcomes

Primary Outcome Measures

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2010
Last Updated
February 24, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01126892
Brief Title
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Advanced Disease,, Resistance,, Intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response
Time Frame
24 months
Title
To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study
Time Frame
24 months
Title
To follow loss of HR (after previous confirmed HR for AP and CHR for CP)
Time Frame
3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stratum 1: Currently participating in Novartis study CAMN107A2109 Written signed and dated informed consent prior to any study procedures being performed Stratum 2: Male or female > 18 years ECOG 0,1,2 ASL/ALT <= 2.5 ULN or <= 5.0 ULN Alcaline Phosfatase <= 2.5 ULN Serum Bilirrubin <= 1.5 ULN Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours Serum Lipase <= 1.5 ULN Exclusion Criteria: Stratum 1 and stratum 2: Reduction of the cardiac function Use of Coumadin Other severe medical concurrent conditions Treatment with medications that prolonged the QT interval. Mayor surgery 15 days before the inclusion in the protocol Pregnant women or lactation Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticlas
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Hospital San José, Bogotá, Colombia
City
Bogota
Country
Colombia
Facility Name
Banco Municipal de Sangre
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Learn more about this trial

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

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