Study title
Nilotinib for First-line Newly Diagnosed CML-CP Patients
Scientific title
Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study (ClinicalTrials.gov NCT03942094)
Indication and most important inclusion criteria
This study includes male or female patients who:
- are at least 18 years old
- have been newly diagnosed with chronic myeloid leukemia (CML) in chronic phase (CP) within 6 months of study entry
- have positive Philadelphia chromosome (Ph+) CML or positive BCR-ABL1 (M-bcr transcript)
- are expected to receive treatment with imatinib within 2 weeks
- have received no other CML treatment except for hydroxyurea and/or anagrelide and/or who have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have adequate organ function
Other criteria may apply.
Short description of intervention
This study will evaluate the efficacy and safety of nilotinib as the first-line treatment for adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP).
All study participants will receive nilotinib 300 mg twice a day. Study participants will be treated and/or followed for 18 months. At this time point, the rate of patients obtaining molecular response (MR) 4.5 will be assessed.
Type of study
First line trial
Current status
recruiting
Study sponsor
Shenzhen Second People's Hospital
Scientific lead / contact
Xin Du, PhD
Shenzhen Second People's Hospital
Principal investigator
Xin Du, PhD
Shenzhen Second People's Hospital
Additional information
Study description in the US register ClinicalTrials.govClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035
Contact: Xin Du, PhD
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Philadelphia chromosome
A certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene)
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Chromosome
A chromosome is a structure of DNA that carries the genetic makeup in the nucleus of the cell. Chromosomes contain giant chain molecules of DNA, coiled and folded as aggregates with specific proteins. Chromosomes ensure that during cell division the hereditary information is evenly distributed to the daughter cells. Normal human body cells have 46 chromosomes. Cancer cells can have a different number and/or structure of chromosomes.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
Imatinib
Imatinib, trade name Glivec/Gleevec, development name STI-571, a first-generation BCR-ABL tyrosine kinase inhibition. Authorized for marketing since 2002 for the treatment of CML and Ph-positive ALL.
Other names: Gleevec|Glivec
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
ECOG
Eastern Cooperative Oncology Group Index to classify the quality of life of cancer patients on a scale ranging from 0 (fully active, able to carry on all predisease activities without restriction) to 5 (death).
Also often referred to as ECOG performance status.
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Ph+
Abbreviation for "Philadelphia-Chromosome-positive", meaning the presence of a certain change in chromosomes (on chromosome 22) found in 95% of patients who have CML. The Philadelphia chromosome results from a mutation that involves the fusion of parts of chromosome 9 and chromosome 22 (the bcr-abl fusion gene).
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
