A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (ENACT)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01126892
First received: May 18, 2010
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia |
Drug: Nilotinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To follow loss of HR (after previous confirmed HR for AP and CHR for CP) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | January 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nilotinib | Drug: Nilotinib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126892
Locations
| Colombia | |
| Hospital San José, Bogotá, Colombia | |
| Bogota, Colombia | |
| Venezuela | |
| Banco Municipal de Sangre | |
| Caracas, Venezuela | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticlas | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01126892 History of Changes |
| Other Study ID Numbers: | CAMN107ACO01 |
| Study First Received: | May 18, 2010 |
| Last Updated: | November 13, 2012 |
| Health Authority: | Colombia: Instituto Nacional De Vigilancia De Medicamentos y Alimentos Venezuela: Instituto Nacional De Higiene Rafael Rangel |
Keywords provided by Novartis:
|
Advanced Disease, Resistance, Intolerance |
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 |
ClinicalTrials.gov processed this record on May 23, 2013