Status:
COMPLETED
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)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia (CML)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00428909
Start Date
November 1 2006
End Date
August 1 2008
Last Update
April 21 2016
Active Locations (1)
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1
Novartis Investigative Site
Seoul, South Korea