This is an international site for Tasigna® (Nilotinib) and is intended for Health Care Professionals outside the U.S. The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.

I am a healthcare professional outside the US I am a US resident I am a patient outside the US
Useful Links
Glossary of Terms

GLOSSARY OF TERMS

Accelerated phase (AP)

Defined as blasts 10% to 19% of white blood cells (WBCs) in peripheral and/or nucleated bone marrow cells, peripheral blood basophils ≤20%, persistent thrombocytopenia (<100 x 109/L) unrelated to therapy, or persistent thrombocytosis (>1000 x 109/L) unresponsive to therapy, increasing spleen size and increasing WBC count unresponsive to therapy, and cytogenetic evidence of clonal evolution. Median survival is <2 years once patients progress to AP/BC.

Apoptosis

A mechanism responsible for the physiologic death of cells. This deletion of cells appears to be inherently programmed. It is characterized by distinctive morphologic changes in the nucleus and cytoplasm, chromatin cleavage at regularly spaced sites, and the endonucleolytic cleavage of genomic DNA (DNA fragmentation) at internucleosomal sites.

BCR-ABL

An abnormal fusion protein that is the single, definitive cause of Ph+ CML and remains the key driver of the disease throughout the chronic phase. Encoded by the BCR-ABL oncogene on the Philadelphia chromosome.

Blast crisis (BC)

Defined as 20% or greater blast cells in the peripheral blood or bone marrow, the presence of extramedullary blast proliferation, and large foci or clusters of blasts in the bone marrow biopsy. Median survival is <2 years once patients progress to AP/BC.

Chronic phase (CP)

Defined as the increased production of myeloid cells in the bone marrow, which results from a balanced, reciprocal translocation of chromosomes 9 and 22. Keeping patients in the chronic phase is vital, as median survival is <2 years once patients progress to AP/BC.

Complete cytogenetic response (CCyR)

Occurs when there are no Ph+ metaphases. Although a positive outcome, patients who achieve CCyR alone are not necessarily safe from progression. (See IRIS and ENESTnd)

Complete hematologic response (CHR)

Occurs when there is a complete normalization of peripheral blood counts with no immature blood cells, leukocyte count is <10 x 109/L, and platelet count is <450 x 109/L.

Cytogenetic test

Measures the number of Philadelphia chromosomes with limited sensitivity (detects 1 abnormal cell out of 20 cells). There are 2 types of cytogenetic tests (see Karyotyping, and Fluorescence in situ hybridization).

Cytogenetic response

Occurs when there is a decrease in the number of Ph+ metaphases.

Fluorescence in situ hybridization (FISH)

A technique in which a DNA probe is labeled with a fluorescent dye that can be seen under a fluorescent microscope and then hybridized with target DNA. The test is used to precisely map genes to a specific region of a chromosome in a prepared karyotype; it can enumerate chromosomes, or detect chromosomal deletions, translocations, or gene amplifications in cancer cells.

Karyotyping

The mapping of the full chromosome set of the nucleus of a cell. The chromosome characteristics are presented as a systematized array of metaphase chromosomes from a photomicrograph of a single cell nucleus arranged in pairs in descending order of size and according to the position of the centromere.

Major cytogenetic response (MCyR)

Occurs when 0% to 35% of the cells still have Ph+ metaphases.

Major molecular response (MMR)

Occurs when there is a 3-log reduction or greater of BCR-ABL mRNA transcripts from standardized baseline (or ≤0.1% BCR-ABL to control gene ratio on the international scale).

Molecular response 4.0 (MR4.0)

Occurs when there is a 4.0-log reduction or greater of BCR-ABL mRNA transcripts from standardized baseline (or ≤0.01% BCR-ABL to control gene ratio on the international scale).

Molecular response 4.5 (MR4.5)

Occurs when there is a 4.5-log reduction or greater of BCR-ABL mRNA transcripts from standardized baseline (or ≤0.0032% BCR-ABL to control gene ratio on the international scale).

Oncogene

Gene that may induce neoplastic transformation. When expressed after structural/regulatory changes, uncontrolled cell proliferation may occur.

Philadelphia chromosome

An abnormal chromosome in hematopoietic stem cells that results from a reciprocal translocation of sections of chromosomes 9 and 22. This translocation fuses portions of the BCR and ABL genes, resulting in the BCR-ABL oncogene that encodes the BCR-ABL fusion protein.

Philadelphia chromosome-positive CML (Ph+ CML)

A myeloproliferative disease characterized by the presence of the abnormal Philadelphia chromosome in hematopoietic stem cells.

Response AT

Stringent 12-month MMR evaluation method used in ENESTnd. Patients with missing or nonevaluable samples or who discontinued early are counted as nonresponders at the primary end points; more stringent evaluation than Response BY.

Response BY

Best result at or prior to time point is considered. The same as “best” or “cumulative” response up to that time point; less stringent evaluation than Response AT.

Real-time quantitative polymerase chain reaction (RT-Q-PCR)

A method of detecting very small numbers of mRNA transcripts. The most sensitive test for measuring residual disease in Ph+ CML.

Topological fit

The quality of relationships between structures; how shapes and structures relate to one another.

Tyrosine kinase

An enzyme that catalyzes the phosphorylation of nonessential amino acid residues in proteins with adenosine triphosphate or other nucleotides as phosphate donors.

TASIGNA Interactive Game

To learn more about RT-Q-PCR monitoring, visit the CML Alliance

View patient-friendly tips that can help improve adherence