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Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279473
First Posted: January 19, 2011
Last Update Posted: August 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.

Condition Intervention Phase
Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia Drug: Nilotinib Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Best hematologic response rate and Best cytogenetic response rate. [ Time Frame: 3 years ]
  • Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL [ Time Frame: 3 years ]

Enrollment: 42
Study Start Date: August 2005
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: AMN107

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279473


Locations
Japan
Novartis Investigative Site
Aichi, Japan
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01279473     History of Changes
Other Study ID Numbers: CAMN107A1101E1
TAS-3-01
First Submitted: December 2, 2010
First Posted: January 19, 2011
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Myelogenous Leukemia
CML
Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive, ph+ ALL
Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action