Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Nilotinib and imatinib mesylate 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 giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Cytologically and cytogenetically confirmed chronic myelogenous leukemia meeting the following criteria:

• Early chronic phase disease (< 6 months from diagnosis)

• Philadelphia chromosome-positive disease

• BCR-ABL-positive

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• ALT and AST = 2.5 times upper limit of normal (ULN) (5.0 times ULN if considered due to leukemia)

• Alkaline phosphatase = 2.5 times ULN (unless considered due to leukemia)

• Serum bilirubin = 1.5 times ULN

• Serum creatinine = 1.5 times ULN

• Serum amylase = 1.5 times ULN

• Serum lipase = 1.5 times ULN

• Normal serum levels of the following or correctable with supplements:

• Potassium

• Total calcium (corrected for serum albumin)

• Magnesium

• Phosphorus

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier method contraception during study and for up to 3 months following completion of study treatment

• No impaired cardiac function, including any of the following:

• LVEF < 45% by MUGA scan or echocardiogram

• Uncontrolled congestive heart failure

• Uncontrolled hypertension

• Uncontrolled angina pectoris

• Myocardial infarction within the past 12 months

• No significant electric heart abnormalities, including any of the following:

• History or active ventricular or atrial tachyarrhythmias

• Congenital long QT syndrome and/or QTc > 450 msec on screening ECG

• No history of acute (within one year) or chronic pancreatitis

• No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

• No acute or chronic liver or renal disease considered unrelated to leukemia

• No known diagnosis of HIV infection

• No other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol

• No other primary malignancy that is currently clinically significant or requires active intervention

PRIOR CONCURRENT THERAPY:

• More than 2 weeks since prior major surgery and recovered

• More than 30 days since prior imatinib mesylate, with a washout period of ≥ 7 days

• More than 4 weeks since prior investigational drug

• No prior hematopoietic stem cell transplantation

• No concurrent therapeutic coumarin derivates (i.e., warfarin, acenocoumarol, phenprocoumon)

• No concurrent medications that would prolong the QT interval

• No concurrent chemotherapy, investigational agents, radiotherapy, or biologic therapy

• Prior treatment with hydroxyurea or anagrelide allowed