Study title
CA180-357 = Decitabine + Dasatinib for Blast Phase CML [USA]
Scientific title
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357) [USA]
(Clinicaltrials.gov No. NCT01498445)
Indication and most important inclusion criteria
This study includes patients age 18 years of age or older with chronic myelogenous leukemia in accelerated phase (CML-AP) or in blast phase (CML-BP). Patients may be previously treated or previously untreated.
Short description of intervention
Patients with accelerated or blast phase CML are treated with a combination of decitabine and dasatinib. They will take dasatinib by mouth once a day and they will receive decitabine by vein for up to 10 days in each 28-day cycle.
Type of study
Treatment of advanced disease
In a single country
Current status
Recruiting
Study sponsor
MD Anderson Cancer Center
Scientific lead / contact
Jorge Cortes
Principal investigator
Jorge Cortes
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study centers / principal investigators
United States
MD Anderson Cancer Center
University of Texas
Houston, Texas
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.
Accelerated Phase
A phase of development of Chronic Myeloid Leukemia between chronic and blast phase. Untreated, the accelerated phase progresses to blast phase within a few months.
Open-label
A clinical trial in which researchers and participants know which treatment is being provided to each patient (opposite to "blinded trials" or "double-blind studies")
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Protocol
The action plan for the research work, which explains key objectives and procedures. In case of a clinical trial, the protocol defines e.g. the purpose of the study, how many people will participate, eligibility criteria, the medical intervention, etc.
Chronic
Long-lasting, slowly developping
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
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.
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.
