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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: December 2, 2010
Last updated: August 22, 2011
Last verified: August 2011
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: 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:

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


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

Inclusion Criteria:

  • Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01279473

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01279473     History of Changes
Other Study ID Numbers: CAMN107A1101E1
Study First Received: December 2, 2010
Last Updated: August 22, 2011

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

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
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 processed this record on May 22, 2017