Leukemia, Myeloid, Chronic, BCR-ABL PositivePhase 3NCT01819389
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance
A Phase 3 study testing Imatinib and Nilotinib in people with Leukemia, Myeloid, Chronic, BCR-ABL Positive, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic, BCR-ABL Positive
- What is being tested?
- Imatinib and Nilotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2012to Aug 2013
- Phase
- Phase 3
- 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
- CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
- Patients with grade II or higher adverse events.
- CML patients not suitable for stem cell transplantation.
Who cannot join
- Patients in blast crisis.
- Pregnant women
- Patients without a contraception method.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Servicio de Hematologia, Hospital Universitario "José E. Gonzalez"
Monterrey, Nuevo León, 64460
About this study
Official title: Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.
The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.
- Being tested
- Imatinib and Nilotinib
- Keywords
- Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib
- Medical subject headings
- Leukemia, Bronchiolitis Obliterans Syndrome, 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.
Imatinib and NilotinibDrug
Also called Gleevec, Tasigna
| Study group | Role | What they receive |
|---|---|---|
| Imatinib and nilotinib combination | Experimental | All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months. Receives: Drug: Imatinib and Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major molecular response
Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
Measured: 6 months
Secondary outcomes (1)
Drugs adverese effects
Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, Chronic, BCR-ABL PositiveStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819389
- Sponsor's protocol ID
- HE12-019
- Status last verified
- Jan 2014
- First submitted
- 26 Oct 2012
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schoffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD. A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol. 2010 Oct;21(10):1990-1998. doi: 10.1093/annonc/mdq076. Epub 2010 May 27.
PubMed 20507881Gomez-Almaguer D, Tarin-Arzaga L, Cantu-Rodriguez O, Ceballos-Lopez A. More about imatinib and nilotinib combination therapy in chronic myeloid leukemia. Acta Haematol. 2013;129(1):18-9. doi: 10.1159/000342455. Epub 2012 Sep 12. No abstract available.
PubMed 22986736Zhu GR, Ji O, Ji JM, Zhang YC, Wu Y, Yu H, Jiang PJ, Shen Q. Combining nilotinib and imatinib improves the outcome of imatinib-resistant blast phase CML. Acta Haematol. 2012;127(3):152-5. doi: 10.1159/000333107. Epub 2012 Jan 27.
PubMed 22286512Gomez-Almaguer D, Saldana-Vazquez R, Tarin-Arzaga L, Herrera-Rojas MA, Vazquez-Mellado de Larracoechea A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Combination of low-dose imatinib plus nilotinib for the treatment of chronic-phase chronic myeloid leukaemia after imatinib failure. Hematology. 2016 Aug;21(7):411-4. doi: 10.1080/10245332.2015.1119369. Epub 2016 Feb 16.
PubMed 26871197
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
- ClinicalTrials.gov ID
- NCT01819389
- Acronym / sponsor ID
- HE12-019
- Keywords
- Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Mar 2013 (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.
The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy.
The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib and nilotinib combination | Experimental | Drug: Imatinib and NilotinibAll patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN)
- Patients with grade II or higher adverse events.
- CML patients not suitable for stem cell transplantation.
Key exclusion criteria (3 listed)
- Patients in blast crisis.
- Pregnant women
- Patients without a contraception method.
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 |
|---|---|---|
| Imatinib and NilotinibAlso: Gleevec, Tasigna | Drug | Imatinib and nilotinib combination |
Primary outcome
Major molecular response
Time frame: 6 months
Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months.
1 secondary outcome
Drugs adverese effects
Time frame: 6 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 7 Jan 2014.
- Background: PubMed 20507881Schoffski P, Reichardt P, Blay JY, Dumez H, Morgan JA, Ray-Coquard I, Hollaender N, Jappe A, Demetri GD. A phase I-II study of everolimus (RAD001) in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors. Ann Oncol. 2010 Oct;21(10):1990-1998. doi: 10.1093/annonc/mdq076. Epub 2010 May 27.
- Background: PubMed 22986736Gomez-Almaguer D, Tarin-Arzaga L, Cantu-Rodriguez O, Ceballos-Lopez A. More about imatinib and nilotinib combination therapy in chronic myeloid leukemia. Acta Haematol. 2013;129(1):18-9. doi: 10.1159/000342455. Epub 2012 Sep 12. No abstract available.
- Background: PubMed 22286512Zhu GR, Ji O, Ji JM, Zhang YC, Wu Y, Yu H, Jiang PJ, Shen Q. Combining nilotinib and imatinib improves the outcome of imatinib-resistant blast phase CML. Acta Haematol. 2012;127(3):152-5. doi: 10.1159/000333107. Epub 2012 Jan 27.
- Derived from this study: PubMed 26871197Gomez-Almaguer D, Saldana-Vazquez R, Tarin-Arzaga L, Herrera-Rojas MA, Vazquez-Mellado de Larracoechea A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Combination of low-dose imatinib plus nilotinib for the treatment of chronic-phase chronic myeloid leukaemia after imatinib failure. Hematology. 2016 Aug;21(7):411-4. doi: 10.1080/10245332.2015.1119369. Epub 2016 Feb 16.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib and Nilotinib in people with Leukemia, Myeloid, Chronic, BCR-ABL Positive, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Major molecular response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819389, which also lists 4 linked publications.
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 7 Jan 2014.