Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (MACS0439)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00786812
First received: November 5, 2008
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia |
Drug: Nilotinib |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months [ Time Frame: 3 - 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 89 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 | Drug: Nilotinib |
| 2 | Drug: Nilotinib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786812
Locations
| Brazil | |
| Novartis Investigative Site | |
| Belo Horizonte, MG, Brazil, 30130-100 | |
| Novartis Investigative Site | |
| Curitiba, PR, Brazil, 80060-900 | |
| Novartis Investigative Site | |
| Rio de Janeiro, RJ, Brazil, 20230-130 | |
| Novartis Investigative Site | |
| Porto Alegre, RS, Brazil, 90035-903 | |
| Novartis Investigative Site | |
| Campinas, SP, Brazil, 13083-970 | |
| Novartis Investigative Site | |
| Jaú, SP, Brazil, 17210-080 | |
| Novartis Investigative Site | |
| Ribeirao Preto, SP, Brazil, 14048-900 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 01401-901 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 05403-000 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00786812 History of Changes |
| Other Study ID Numbers: | CAMN107ABR03 |
| Study First Received: | November 5, 2008 |
| Last Updated: | February 20, 2013 |
| Health Authority: | United States: Food and Drug Administration Brazil: National Health Surveillance Agency |
Keywords provided by Novartis:
|
Leukemia adult chronic myeloid leukemia imatinib nilotinib |
Additional relevant MeSH terms:
|
Blast Crisis Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013