Phase
Condition
Leukemia
Chronic Myeloid Leukemia
Platelet Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients must meet all of the following criteria in order to be eligible for participationin the study:
Able to give written informed consent;
Male or female patient ≥ 18 years old;
Confirmed diagnosis of CML in chronic or accelerated phase according to EuropeanLeukemiaNet guideline as of 2013;
Available information regarding resistance to the therapy with least one 2-ndgeneration Bcr-Abl inhibitor (dasatinib or nilotinib or bosutinib), or intolerance ofapproved Bcr-Abl inhibitors, or presence of T315I mutation irrespective of treatmenthistory;
In case of previous history of blast crisis phase of CML at least 6 months arerequired to pass after the end of blast crisis phase before the first dose of PF-114;
ECOG performance status ≤ 2 (see Appendix 2);
Adequate renal function defined as serum creatinine ≤ 1.5 times upper limit of normal (ULN);
Adequate hepatic function defied as:
serum bilirubin ≤ 1.5 X ULN unless a patient is diagnosed with Gilbert'ssyndrome;
serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 XULN;
alkaline phosphatase ≤ 2.5 X ULN;
INR ≤ 1.5 X ULN;
Adequate cardiac function defined as LVEF > 40 % by echocardiogram;
QTcF < 470 ms;
Patient has recovered (to Grade 1 or less according to NCI CTCAE V 4.0) fromtoxicities (excluding alopecia) associated with any prior treatments;
Female patients of childbearing potential and male patients who have female partnersof childbearing potential must agree with abstinence from sexual relations or useeffective methods of contraception throughout participation in the study;
Ability to comply with study procedures in the Investigator's opinion.
Exclusion
Exclusion Criteria: Patients must not meet any of the following criteria in order to be eligible forparticipation in the study:
Use of the following previous therapy:
chemotherapy ≤ 21 days (except hydroxyurea for which washout is not required)prior to the first dose of PF-114 mesylate; оr nitrosoureas оr mitomycin С ≤ 42days prior to the first dose of PF-114 mesylate;
approved tyrosine kinase inhibitors or investigational agents ≤ 4 days prior tothe first dose of PF-114;
radiotherapy ≤ 28 days prior to the first dose of PF-114 ;
autologous оr allogeneic stem сеll transplant < 90 days prior to enrollment;
Significant uncontrolled cardiac disease;
Sustained uncontrolled hypertension ≥ Grade 2 (according to NCI CTC AE v4);
Patient is taking medicinal products known to prolong the QT interval on theelectrocardiogram, unless they are absolutely necessary in the opinion of theinvestigator;
Evidence of on-going graft versus host disease (GVHD), or GVHD requiringimmunosuppressive therapy. Patients should be off immunosuppressive therapy forprophylaxis and/or treatment for at least 14 days prior to the first dose of PF-114;
Major surgery within 35 days prior to enrollment;
Uncontrolled intercurrent illness including, but not limited to the following: activesystemic infection, uncontrolled seizure disorder, psychiatric or social circumstancesthat would limit compliance with study requirements or misrepresent results of thestudy;
Patient is unable to swallow study drug or has gastro-intestinal disorders that couldnegatively affect oral absorption of PF-114 ;
Any malignancy other than CML within the past 3 years (except for non-melanoma skincancer or cervical cancer in situ).
Pregnancy or breast feeding.
Study Design
Study Description
Connect with a study center
Federal Haematological Scientific Center
Moscow, 125167
Russian FederationSite Not Available
Moscow City Centre of Hematology based on City Hospital named by S.Botkin
Moscow, 125284
Russian FederationSite Not Available
Federal Almazov North-West Medical Research Centre
St. Petersburg,
Russian FederationSite Not Available

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