Neoplasms

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Leukemia

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

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Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

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Chronic Graft Versus Host Disease

Myeloid Leukemia

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Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Nilotinib

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.

Imatinib

Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.

Nilotinib (AMN107)

Novartis Pharmaceuticals

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib

Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.

Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.

Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Belgium

Germany

Japan

Korea, Republic of

Poland

Region of Enrollment

Study Director

Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib

The trial was terminated early, so only 6 patients were enrolled.

Durable Complete Cytogenetic Response Rate

Overall Study

Translocation, Genetic

Chromosome Aberrations

All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

nilotinib

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

A Multi-center, Single Arm Study of Nilotinib in Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Patients With Low Imatinib Trough Plasma Concentrations

Treatment failure events from time of study entry in Complete molecular response-Chronic phase (CML-CP) participants with low imatinib trough concentrations less than 850 nanogram per milliliter (\<850 ng/mL) treated with nilotinib as defined in European LeukemiaNet (ELN)-guideline.

Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as CCyR at 12 cycles if the patient met the CCyR criteria at the Cycle 12 Visit.

Major molecular response is defined as values equal or below 0.1% on the International Scale.

Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.

Durations of major/complete cytogenetic response is defined as the time from the first documentation of the major/ complete response to the first documentation of the disease progression.

Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.

Progressions free survival is defined as time between Day 1 cycle 1 and time to first documented disease progression or death. Disease progression will be determined as per response criteria.

Overall survival time is defined as the time from the treatment start to the date of death due to any reason.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.

Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical examination or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Participants received nilotinib 300 mg, BID po, every 12 hours in continuous 28-day cycle up to 2 years.

Caucasian

Race/Ethnicity, Customized

The study was terminated early due to slow enrollment.

The overall number of participants considered for analysis was "0" due to the premature termination of the study and low enrollment; The efficacy and quality of life assessments were not collected and reported in the study.

Number of Treatment Failure Events up to 2 Years

European LeukemiaNet (ELN)-Defined Optimal Responses

Loss of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR) on Nilotinib

Duration of Complete Cytogenetic Response (CCyR), Major Molecular Response (MMR) and Complete Molecular Response (CMR)Achieved on Nilotinib

Event-free Survival (EFS), Progression-free Survival (PFS) and Overall Survival (OS) up to 2 Years

European LeukemiaNet (ELN)-Defined Suboptimal Events

Number of Participants Reported Adverse Events

Participants received nilotinib 300 milligram (mg) twice daily (bid) through the mouth (po), every 12 hours in a continuous 28-day cycle up to 2 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)	NCT00519090	Myelogenous Leu...	Imatinib Nilotinib (AMN1...	18 Years -	Novartis
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)	NCT00519090	Myelogenous Leu...	Imatinib Nilotinib (AMN1...	18 Years -	Novartis
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations	NCT01131325	CML Philadelphia Ch... Chronic Myeloge...	nilotinib	18 Years -	Novartis

Spots Global Cancer Trial Database for philadelphia chromosome positive (ph+)