Chronic Myeloid LeukemiaEarly Phase 1NCT03228303
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
A Early Phase 1 study testing Nilotinib 150 MG [Tasigna] and Imatinib 400mg in people with Chronic Myeloid Leukemia, run by Assiut University.
Trial summary
Nilotinib vs imatinib in patients with newly diagnosed CML-CP Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Nilotinib 150 MG [Tasigna] and Imatinib 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Aug 2020
- Phase
- Early Phase 1
- 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
Who may be able to join
- chronic phase CML not received treatment
- Pts with no heart disease
- Pts with no abnormal cholesterol level
Who cannot join
- Any pts treated before with diff. Treatment
- Pts. With past history of heart problems
- Pts. With abnormal cholesterol level
About this study
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
Read the detailed description
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Nilotinib 150 MG [Tasigna], Imatinib 400mg
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nilotinib 150 MG [Tasigna]Drug
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
Imatinib 400mgDrug
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
| Study group | Role | What they receive |
|---|---|---|
| Chronic phase CML treated by nilotinib | Active comparator | Newly diagnosed Receives: Drug: Nilotinib 150 MG [Tasigna] |
| Chronic phase CML treated by imatinib | Active comparator | Newly diagnosed Receives: Drug: Imatinib 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
Overall survival rate in years
Measured: 3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
cholesterol level in mg
Measured: 3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
heart state by assessment by ECG
Measured: 3 years cutoff
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
free survival rate in years
Measured: 3 years cutoff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Dec 2017 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean George Maxwell, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228303
- Sponsor's protocol ID
- Jgmaxwell
- Status last verified
- Oct 2017
- First submitted
- 16 Jul 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03228303
- Acronym / sponsor ID
- Jgmaxwell
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 24 Jul 2017 (actual)
- 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.
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
Detailed description
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic phase CML treated by nilotinib | Active comparator | Drug: Nilotinib 150 MG [Tasigna]Newly diagnosed |
| Chronic phase CML treated by imatinib | Active comparator | Drug: Imatinib 400mgNewly diagnosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic phase CML not received treatment
- Pts with no heart disease
- Pts with no abnormal cholesterol level
Key exclusion criteria (3 listed)
- Any pts treated before with diff. Treatment
- Pts. With past history of heart problems
- Pts. With abnormal cholesterol level
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 |
|---|---|---|
| Nilotinib 150 MG [Tasigna]Nilotinib vs imatinib in patients with newly diagnosed CML-CP | Drug | Chronic phase CML treated by nilotinib |
| Imatinib 400mgNilotinib vs imatinib in patients with newly diagnosed CML-CP | Drug | Chronic phase CML treated by imatinib |
Primary outcome
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
Time frame: 3 years cutoff
Overall survival rate in years
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
Time frame: 3 years cutoff
cholesterol level in mg
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
Time frame: 3 years cutoff
heart state by assessment by ECG
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
Time frame: 3 years cutoff
free survival rate in years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nilotinib 150 MG [Tasigna] and Imatinib 400mg in people with Chronic Myeloid Leukemia, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years (time frame: 3 years cutoff). The study lists 4 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 10 Oct 2017.