A Study of Oral Nilotinib in Adults With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) - Full Text View

A Study of Oral Nilotinib in Adults With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00384228

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 (Philadelphia Chromosome Positive)	Drug: Nilotinib	Phase I Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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 CML, or Relapse/Refractory Ph+ALL

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety evaluation assessed by dose limiting toxicity within first cycle of 28 day treatment and AEs within 3 cycles
Phamacokinetic (PK) profile of single and multiple doses

Secondary Outcome Measures:

Anti-leukemic activity within 3 cycles of 28 days treatment
Bone marrow and/or blood assessments to detect the presence of Bcr-Abl transcript and mutational analysis of Bcr-Abl before, during and after therapy.

Estimated Enrollment:	18
Study Start Date:	May 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Diagnosed as Ph+ ALL who are either relapsed after or refractory to standard therapy
Diagnosed as CML in blast crisis or accelerated phase or chronic phase who are resistant or intolerant to imatinib
Performance status is normal or ambulatory and capable of all self-care Exclusion Criteria
A history of significant or serious uncontrolled cardiovascular disease
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of nilotinib
Patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384228

Locations


Japan

	Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CAMN107A1101
First Received:	October 5, 2006
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00384228
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Chronic Myelogenous Leukemia

Acute Lymphoblastic Leukemia

Study placed in the following topic categories:

Chromosomal abnormalities

Philadelphia Chromosome

Leukemia, Lymphoid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Immunoproliferative Disorders

Chronic myelogenous leukemia

Hematologic Diseases

Myeloproliferative Disorders

Leukemia, Myeloid

Imatinib

Leukemia

Lymphatic Diseases

Chromosome Aberrations

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoproliferative Disorders

Bone Marrow Diseases

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Neoplasms by Histologic Type

Immune System Diseases

Translocation, Genetic

ClinicalTrials.gov processed this record on October 29, 2008