Study of Treatment With 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

— MACS0439  

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: NCT00786812
• Other study ID #: CAMN107ABR03
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: February 21, 2017
• Start date: August 2008
• Est. completion date: January 2012

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. patients currrently participating in Novartis study CAMN107A2109

2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)

3. males or females =18 years of age

4. WHO Performance Status of = 2

5. patients must have the following laboratory values: ALT and AST = 2.5 x ULN or = 5.0 x ULN if considered due to tumor

Exclusion Criteria:

1. Impaired cardiac function; use of therapeutic coumarin derivatives

2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days

3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control

4. patients who have received chemotherapy = 1 week or who are within 5 half-lives of their last dose of chemotherapy

5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy

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
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Jaú	SP
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Ribeirao Preto	SP
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months		3 - 24 months

External Links

•   Results for CAMN107ABR03 from the Novartis Clinical Trials website.