Management of Transformed Chronic myeloid leukaemia: Ponatinib and Intensive chemotherapy: a dose finding study - Matchpoint

niversity of Birmingham0 sites15 target enrollmentDecember 30, 2013

Overview

No summary available.

Registry

who.int

Start Date

December 30, 2013

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•All of the following:
•Ph\-positive or BCR\-ABL positive CML in blastic transformation. Defined as one or more of the following being present:
•oBlasts \=30% in peripheral blood or bone marrow
•oExtramedullary blast proliferation or large foci or clusters of blasts in the bone marrow biopsy
•Suitable for intensive chemotherapy (FLAG\-IDA)
•Adequate renal function defined as serum creatinine \=1\.5 X upper limit of normal (ULN)
•Adequate liver function defined as:
•oTotal bilirubin \< 1\.5 X ULN, unless due to Gilbert’s syndrome
•oAlanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2\.5 X ULN (\< 5 X ULN if liver involvement with leukaemia. Patients with disordered liver function \>5 X ULN due to leukaemia may enter with a dose reduction of FLAG\-IDA as per local guidelines and will be considered on a per patient basis following discussion with the Chief Investigator and Trial Office.)
•Normal pancreatic status defined as:

•Any of the following will exclude:
•Received chemotherapy other than hydroxycarbamide, anagrelide, low dose arabinosylcytarabine (LDAC), steroids, or interferon within 4 weeks of registration
•Changed TKI therapy more than once since confirmation of blast phase CML or had prior treatment with ponatinib at any time.
•Previous treatment with intensive acute leukaemia\-style chemotherapy (FLAG\-IDA). (Unless treatment was during an initial blast phase which returned to chronic phase for a prolonged period of time and the patient is now in a second blast phase.)
•Prior allogeneic or autologous Stem Cell Transplant
•Significant or active cardiovascular disease, specifically including but not restricted to:
•oMyocardial infarction, stroke or revascularization within 12 months prior to registration
•oHistory of clinically significant atrial arrhythmia
•oAny history of or ventricular arryhthmia
•oUnstable angina or transient ischemic attack within 6 months prior to registration