Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (NCT00809211) | Clinical Trial Compass
CompletedPhase 2
Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
United States, Germany, Ireland40 participantsStarted 2008-10
Plain-language summary
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Cytogenetically confirmed chronic myelogenous leukemia (CML) by standard conventional cytogenetic analysis of bone marrow\*
* Newly diagnosed disease (within the past 6 months) NOTE: \*FISH cannot be used
* In chronic phase, as defined by the following:
* Less than 15% blasts in peripheral blood and bone marrow
* Less than 30% blasts plus promyelocytes in peripheral blood and bone marrow
* Less than 20% basophils in peripheral blood
* Platelet count ≥ 100,000/mm\^3
* No evidence of extramedullary leukemic involvement, except for hepatosplenomegaly
* Philadelphia chromosome-positive disease as demonstrated by (9;22) translocation (presence of Bcr-Abl)
* A review of ≥ 20 metaphases is required
* No previously documented T315I mutations
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 2.5 times ULN
* Estimated glomerular filtration rate ≥ 30 mL/min
* Serum amylase and lipase ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN (unless related to CML)
* Potassium ≥ lower limit of normal (LLN)
* Magnesium ≥ LLN
* Phosphorous ≥ LLN
* Total calcium ≥ LLN (corrected for serum albumin)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No impaired cardiac function including, but not limited to, any of the following:
* LVEF \< 45% or \< LLN by ECHO
* Inability to determine the QT interval on ECG
…
What they're measuring
1
Complete cytogenetic response rate at 6 months as assessed by metaphase analysis