Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Acetaminophen; Imatinib Mesylate

Criteria

Inclusion criteria:

• Ability to provide written informed consent prior to participation to the study.

• Male or female patients ≥ 18 and ≤ 75 years of age

• Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis). FISH analysis will not be accepted.

• Diagnosis of CML in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Bcr-Abl

• Documented chronic phase CML as defined by:

• < 15% blasts in peripheral blood and bone marrow

• < 30% blasts plus promyelocytes in peripheral blood and bone marrow

• < 20% basophils in the peripheral blood

• ≥ 100 x 109/L (≥ 100,000 /mm3) platelets

• No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly

• Adequate end organ function as defined by:

• total bilirubin < 1.5 x ULN

• SGOT and SGPT < 2.5 x UNL

• creatinine < 1.5 x ULN

• Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug

Exclusion criteria:

• Patients in late chronic phase, accelerated phase, or blastic phase are excluded

• Patients who have received other investigational agents

• Patients who received imatinib for any duration prior to study entry

• Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide

• Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention

• Patients who are:

• pregnant

• breast feeding

• of childbearing potential without a negative pregnancy test prior to baseline

• male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial

• Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential

• Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes, chronic renal disease)

• Patient previously received radiotherapy to ≥ 25% of the bone marrow

• Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery

• Patients with an ECOG Performance Status Score ≥ 3

• Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x IULN, with the exception of patients on treatment with oral anticoagulant

• Patients with known positivity for human immunodeficiency virus (HIV)

• baseline testing for HIV is not required

• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent

• Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment

• Patients who are chronic users of acetaminophen or medications containing acetaminophen.

• Patients who received acetaminophen or medications containing acetaminophen within 72 hours prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply