EUCTR2011-005989-38-DK
Active, not recruiting
Phase 1
A SAFETY AND EFFICACY STUDY OF ADDING LOW DOSE PEGYLATED IFN-?LPHA 2B TO STANDARD DOSE DASATINIB IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA - NordCML007
orwegian University of Science and Technology0 sites35 target enrollmentNovember 19, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orwegian University of Science and Technology
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\.Age \=18\- 70 years of age
- •2\.Diagnosis of chronic myeloid leukemia in chronic phase (CML\-CP) associated with BCR\-ABL1 quantifiable by RQ\-PCR (IS)
- •3\.No other current or planned anti\-leukemia therapies excluding hydroxyurea treatment for up to two months.
- •4\.ECOG Performance status 0,1, or 2
- •5\.Adequate organ function as defined by: Total bilirubin \< 1\.5 x ULN (ULN \= upper limit of normal in a local institution lab) in absence of Gilbert genotype; ASAT and ALAT \< 2\.5 x ULN. Creatinine \< 2x ULN. Potassium, magnesium and phosphate not below LLN (LLN\= lower level of normal)
- •6\.Life expectancy of more than 12 months in the absence of any intervention
- •7\.Patient has given written informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.Prior accelerated phase or blast crisis
- •2\.Uncontrolled or significant cardiovascular disease, including any of the following:
- •a.A myocardial infarction within 6 months
- •b.Uncontrolled angina within 3 months
- •c.Congestive heart failure within 3 months
- •d.Diagnosed or suspected congenital long QT syndrome
- •e.Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
- •f.Prolonged QTcF interval \> 450 msec on pre\-entry ECG
- •3\.Atypical BCR\-ABL1 transcript not quantifiable by RQ\-PCR.
- •4\.Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study of safety and effect of adding a low dose of interferon to dasatinib in patients with newly diagnosed chronic myeloid leukemia (CML)EUCTR2011-005989-38-SEorwegian University of Science and Technology22
Active, not recruiting
Phase 1
A study of safety and effect of adding a low dose of interferon to dasatinib in patients with newly diagnosed chronic myeloid leukemia (CML)EUCTR2011-005989-38-NOorwegian University of Science and Technology35
Active, not recruiting
Not Applicable
A study of safety and effect of adding a low dose of interferon to dasatinib in patients with newly diagnosed chronic myeloid leukemia (CML)Chronic myeloid leukemiaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2011-005989-38-FIorwegian University of Science and Technology35
Recruiting
Phase 3
Investigation of the Effect of Senagraph on colon preparatioChronic Kidney Disease.Chronic kidney disease (CKD)IRCT20180412039283N2Shahid Beheshti University of Medical Sciences122
Completed
Not Applicable
Evaluation of the safety and efficacy of low dose transgenic rice containing peptides from Japanese cedar pollen allergens.JPRN-UMIN000016078The Jikei University, School of Medicine21