Chronic Myeloid Leukemia, Chronic PhaseCCMLJNCT02977312
Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by Hikma Pharmaceuticals LLC at 3 sites in Jordan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- What is being tested?
- Imatinib
- How many people
- 91 participants
- Where
- 3 sitesJordan
- Study dates
- Aug 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)
Who may be able to join
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR
- Written informed consent
Who cannot join
- Age <18 years
- CML in accelerated phase
- CML in blast crisis
- CML with mutation(s) in the BCR-ABL gene
- Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)
Trial locations and contacts
3 sites in 1 country.
Jordan3 sites
Al Bashir Hospital
Amman
Jordan University Hospital
Amman
King Hussein Cancer Center
Amman
About this study
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
Read the 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")
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Being tested
- Imatinib
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Cemivil
Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Cytogenetic Response (CCyR)
Measured: 12 months
Rate of Major Molecular Response (MMR)
Measured: 12 months
Secondary outcomes (1)
Incidence of treatment-emergent adverse events (AEs)
(Safety \& Tolerability)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdallah Abbadi, Professor, Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977312
- Sponsor's protocol ID
- Cemivil-2011-01
- Acronym
- CCMLJ
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan
- ClinicalTrials.gov ID
- NCT02977312
- Acronym / sponsor ID
- CCMLJ / Cemivil-2011-01
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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")
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP)
Key inclusion criteria (3 listed)
- Age ≥18 years
- Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil treatment since its registration in Jordan and who confirmed CHR
- Written informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- CML in accelerated phase
- CML in blast crisis
- CML with mutation(s) in the BCR-ABL gene
- Contraindications to the administration of the study drug according to the approved Summary of Product Characteristics (SPC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: CemivilObservation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil | Drug | – |
Primary outcome
Rate of Complete Cytogenetic Response (CCyR)
Time frame: 12 months
Rate of Major Molecular Response (MMR)
Time frame: 12 months
1 secondary outcome
Incidence of treatment-emergent adverse events (AEs)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Myeloid Leukemia, Chronic Phase
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Abbadi, Professor principal investigator
Jordan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by Hikma Pharmaceuticals LLC at 3 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Cytogenetic Response (CCyR) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.