An observational study in Patients Diagnosed as Chronic Meyloid Leukemia, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Assiut University · Observational
Determine the effects of tyrosine kinase Inhibitors on liver enzymes and electrolytes in relation to hematologic response in patients with chronic phase chronic meyloid leukemia.. Assiut University Hospital insight..
CML is a myeloproliferative neoplasm with unique biological and clinical features.
CML accounts for 15_20% of newly diagnosed cases of leukemias among adults. CML can present in three clinical phases : chronic phase, accelerated phase and blast phase.
CML is characterized by prodction of a breakpoint cluster region abelson(BCR-ABL) fusion protein with ABL kinase activity. This is due to reciprocal translocation between chromosome 9 and 22.
Imatinib \& Nilotinib, an ABL kinase inhibitors, which has revolutionized the CML therapy, are a selective tyrosine kinase inhibitors.
The aim of the study is to determine the changes of liver enzymes and electrolytes in relation to hematologic response during treatment period.
Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed patients with chronic phase chronic meyloid leukemia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Administration of tyrosine kinase inhibitors (Imatinib in a dose of 400mg/day \& Nilotinib in adose of 600mg/day)
Also known as: Glivic & Tasigna
Follow up liver enzymes as AST, ALT, ALP and GGT before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib).
Changes happen in liver enzymes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib \& Nilotinib) which are assessed by measuring liver enzymes as AST, ALT, ALP, GGT before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene.
Time frame: 6 months
Follow up electrolytes as Na, K, Ca and P before starting treatment and during the period of treatment by Tyrosine Kinase Inhibitors (Imatinib & Nilotinib)
Changes happen in electrolytes after a period of treatment by Tyrosine Kinase Inhibitors (Imatinib \& Nilotinib) which are assessed by measuring electrolytes levels before starting treatment and during the period of treatment and the relation between these changes and the hematologic response to the treatment that is assessed by CBC and BCR-ABL Gene
Time frame: 6 months
Started Jan 2020 (actual). Primary completion is estimated for Feb 2022, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.