Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Philadelphia Chromosome

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Translocation, Genetic

Chromosome Aberrations

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Nilotinib

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Novartis Pharmaceuticals

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale \[IS\]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).

Major Molecular Response (MMR) value at molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized InteYesrferon versus STI571 (IRIS) study or 0.1 percent (%) per International Scale (IS).

Number of participants experiencing either a greater than or equal to (\>or=) 1, \>or= 2, or \>or= 3 log10 reduction in Bcr-Abl transcript levels from Baseline to End of Cycle (EOC) 45 (Day1219 - Day1302) were presented.

The median time to best molecular response, defined as the time (in months) from the date of enrollment to the date when the maximum reduction in Bcr-Abl transcript level was observed.

Duration of best molecular response, defined as the time (in months) from the date of best molecular response to a date when an increase in \>1 log10 was observed

Event-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of any of the following: loss of complete hematological response (CHR), loss of Complete cytogenetic response (CCyR), \>1 log increase in Bcr-Abl transcripts from the lowest recorded value, progression to accelerated or blast phase, and death.

Progression-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of progression to Accelerated phase (AP) or Blast crisis (BC) phase, chronic myelogenous leukemia (CML) or death. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.

Overall survival was defined as the number of participants from enrollment to the date of death.

The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.

Participants orally received a total of 600 mg dose of Nilotinib as a as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).

Participants orally received a total of 600 mg dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules BID for 12 cycles (each cycle = 28 days).

Age, Continuous

Sex: Female, Male

Caucasian

Black

Asian

Other

Race/Ethnicity, Customized

The analysis was performed in Intent-to-treat (ITT) population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.

The study was terminated on 31 March 2012 due to slower than planned enrollment, resulting in a small sample size, no inferential analyses were conducted.

Study Director

Baseline

Month 12

The analysis was performed in intent-to-treat (ITT) population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure at specified time point.

Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment.

Number of Participants Who Achieved Major Molecular Response (MMR)

>or=1 log10 reduction

>or= 2 log10 reduction

>or= 3 log10

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.

Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12

Median Time to Best Molecular Response

Since only one participant met the criterion of losing response (that is \[i.e.,\] an increase in \> 1 log10 is observed after the occurrence of best molecular response), the analysis was not performed. Hence data was not collected and reported.

Duration of Best Molecular Response

Event

Censor

The analysis was performed in ITT population, defined as all enrolled participants who received at least 1 dose of study drug and had at least 1 post-baseline assessment. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.

Number of Participants With an Event-free Survival

Missing

Number of Participants With a Progression-free Survival

Number of Participants With an Overall Survival

Participants orally received a total of 600 milligram (mg) dose of Nilotinib as 50-mg and 200-mg hard gelatin capsules twice daily (BID) for 12 cycles (each cycle = 28 days).

Spots Global Cancer Trial Database for Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial