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This study assessed the efficacy and safety of generic imatinib in patients with chronic myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label, prospective study combined with retrospective data collection from files of patients with a diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s) additional to the daily practice were performed
Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated with Cemivil who achieve optimal response :
- Complete hematologic response (CHR) at 3 months;
- Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No Ph+ metaphases);
- Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to ABL1 ≤0.1% on the International Scale];
Assess the safety and tolerability of Cemivil after one year of treatment, based on:
- Incidence, severity, and relationship of adverse events (AEs) to the study medication;
- Serious AEs;
- AEs leading to permanent treatment discontinuation;
- Clinically relevant changes in laboratory tests (according to laboratory reference ranges).
Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy "first-line patients". N=58 switched from patented imatinib to generic imatinib "switched patients")
Observational Model: Cohort
Chronic Myeloid Leukemia, Chronic Phase
Al Bashir Hospital
Hikma Pharmaceuticals LLC
Published on BioPortfolio: 2016-12-01T16:08:22-0500
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The phase of chronic myeloid leukemia following the chronic phase (LEUKEMIA, MYELOID, CHRONIC-PHASE), where there are increased systemic symptoms, worsening cytopenias, and refractory LEUKOCYTOSIS.
Clonal hematopoetic disorder caused by an acquired genetic defect in PLURIPOTENT STEM CELLS. It starts in MYELOID CELLS of the bone marrow, invades the blood and then other organs. The condition progresses from a stable, more indolent, chronic phase (LEUKEMIA, MYELOID, CHRONIC PHASE) lasting up to 7 years, to an advanced phase composed of an accelerated phase (LEUKEMIA, MYELOID, ACCELERATED PHASE) and BLAST CRISIS.
The initial phase of chronic myeloid leukemia consisting of an relatively indolent period lasting from 4 to 7 years. Patients range from asymptomatic to those exhibiting ANEMIA; SPLENOMEGALY; and increased cell turnover. There are 5% or fewer blast cells in the blood and bone marrow in this phase.
A myelodysplastic/myeloproliferative disorder characterized by myelodysplasia associated with bone marrow and peripheral blood patterns similar to CHRONIC MYELOID LEUKEMIA, but cytogenetically lacking a PHILADELPHIA CHROMOSOME or bcr/abl fusion gene (GENES, ABL).
An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
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