Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Expanded access is currently available for this treatment.

Verified by Novartis, May 2009

First Received: December 18, 2006 Last Updated: May 26, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00413270

Purpose

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

Condition	Intervention	Phase
Chronic Myelogenous Leukemia	Drug: nilotinib	Phase III

Study Type:	Expanded Access
Official Title:	A Canadian Open-Label, Multicenter, Expanded Access Study of Oral 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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Novartis:

Study Start Date:

December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
World Health Organization (WHO) performance status ≤ 2

Exclusion Criteria:

Cytopathologically confirmed central nervous system (CNS) infiltration
Impaired cardiac function
Use of therapeutic coumarin derivatives
Acute chronic liver or renal disease unrelated to tumor
Other uncontrolled medical conditions
Treatment with hematopoeitic colony stimulating factors
Treatment with medications that have potential to prolong the QT interval
Another malignancy currently clinically significant or requires active intervention

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413270

Contacts

Contact: Novartis Pharmaceuticals

+1 800-340-6843

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAMN107ACA01
Study First Received:	December 18, 2006
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00413270 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Novartis:

Imatinib resistant
Imatinib intolerant
CML- blast crisis
CML- Accelerated phase

CML- chronic phase
nilotinib
Imatinib resistant or- intolerant Chronic myelogenous leukemia in blast crisis, accelerated phase or chronic phase

Study placed in the following topic categories:

Imatinib
Blast Crisis
Leukemia
Hematologic Diseases
Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Leukemia, Myeloid
Bone Marrow Diseases
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Blast Crisis
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors
Pharmacologic Actions

Imatinib
Leukemia
Neoplasms
Neoplastic Processes
Pathologic Processes
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on September 11, 2009