An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment (MACS0999)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00980018

CAMN107AUS17

Details and patient eligibility

About

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients ≥ 18 years of age
2. Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
5. CML-CP patients initiated on any dose of imatinib
6. Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion criteria

1. Loss of CHR or cytogenetic response
2. Prior accelerated phase or blast phase CML
3. Previously documented T315I mutation
4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
6. Treatment with other investigational agents within 30 days of Day 1.
7. History of non-compliance to medical regimens or inability to grant consent.
8. Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

nilotinib

Experimental group

Description:

Participants received two 150 \[a total of 300 mg at each dosing\] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules \[a total of 400 mg at each dosing\] for patients enrolled prior to Protocol Amendment 1).

Treatment:

Drug: Nilotinib