Chronic Myeloid Leukemia, Chronic Phase Clinical Trial
Official title:
Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
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
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")
;
Observational Model: Cohort
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04006847 -
Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06368414 -
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
|
Phase 2 | |
| Active, not recruiting |
NCT04126681 -
A Pivotal Study of HQP1351 in Patients With Chronic Myeloid Leukemia in Chronic Phase
|
Phase 2 | |
| Not yet recruiting |
NCT05543161 -
"Peripheral Blood Dipeptidylpeptidase IV (CD26) Positive Leukemic Stem Cells in Chronic Myeloid Leukemia as a Diagnostic Marker"
|
||
| Recruiting |
NCT05638763 -
Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia
|
Phase 2 | |
| Recruiting |
NCT03610971 -
Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors
|
Phase 2 | |
| Completed |
NCT03332511 -
Efficacy and Safety of Nilotinib in CML-CP
|
Phase 4 | |
| Active, not recruiting |
NCT06233890 -
The Analysis of Fatigue on Tyrosine Kinase Inhibitor Therapy in Chronic Myeloid Leukaemia
|
||
| Completed |
NCT03882281 -
Pharmacokinetics Profiles of HQP1351 Under Fasting and High-fat Meals in Patients With Chronic Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT03459534 -
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
|
Phase 3 | |
| Completed |
NCT03885830 -
Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
|
||
| Active, not recruiting |
NCT04147533 -
Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients With Chronic Myeloid Leukemia
|
Phase 2 | |
| Recruiting |
NCT03942094 -
Nilotinib for First-line Newly Diagnosed CML-CP Patients
|
Phase 3 | |
| Active, not recruiting |
NCT03933852 -
Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
|
||
| Recruiting |
NCT05311943 -
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
|
Phase 3 | |
| Active, not recruiting |
NCT04160546 -
Study to Evaluate the Reinduction and Second Stop of TKI With Ponatinib in CML in Molecular Response (ResToP)
|
Phase 2 | |
| Recruiting |
NCT04677439 -
Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
|
Phase 4 | |
| Active, not recruiting |
NCT03722420 -
Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)
|
Phase 3 | |
| Not yet recruiting |
NCT06163430 -
CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
|
Phase 1 | |
| Recruiting |
NCT06119269 -
Ponatinib in CML Patients in Chronic Phase
|