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

NCT00786812 | Completed Phase 4

• 1 other identifier: CAMN107ABR03
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Chronic Myeloid Leukemia

Keywords

Leukemia; adult chronic myeloid leukemia; imatinib; nilotinib

Outcome Measures

Primary Outcomes (1)

• Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months

  3 - 24 months

Study Arms (2)

CAMN107A2109 Extension Patients

OTHER

Drug: Nilotinib

AMN107 Naive

OTHER

Drug: Nilotinib

Interventions

Nilotinib DRUG

AMN107 Naive; CAMN107A2109 Extension Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients currrently participating in Novartis study CAMN107A2109
• imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
• males or females ≥18 years of age
• WHO Performance Status of ≤ 2
• patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

You may not qualify if:

• Impaired cardiac function; use of therapeutic coumarin derivatives
• patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
• patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
• patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
• ,.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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Novartis Investigative Site

Curitiba, Paraná, 80060-900, Brazil

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Novartis Investigative Site

Campinas, São Paulo, 13083-970, Brazil

Location

Novartis Investigative Site

Jaú, São Paulo, 17210-080, Brazil

Location

Novartis Investigative Site

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01401-901, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: August 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

BR (9)