Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 10:48 AM
Study NCT ID:
NCT02977312
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
Sponsor:
Hikma Pharmaceuticals LLC
Organization:
Study Overview
Official Title:
Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCMLJ
Brief Summary:
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
Detailed Description:
Primary objectives
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")
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")
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: