Leukemia, Myeloid, Chronic, BCR-ABL Positive Clinical Trial
Official title:
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.
| Verified date | January 2014 |
| Source | Hospital Universitario Dr. Jose E. Gonzalez |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Mexico: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | August 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Patients in blast crisis. - Pregnant women - Patients without a contraception method. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Servicio de Hematologia, Hospital Universitario "José E. Gonzalez" | Monterrey | Nuevo Leon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | Novartis Pharmaceuticals |
Mexico,
Gómez-Almaguer D, Tarín-Arzaga L, Cantú-Rodríguez O, Ceballos-López 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. — View Citation
Schöffski 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):1990-8. doi: 10.1093/annonc/mdq076. Epub 2010 May 27. — View Citation
Zhu 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adherence | Every month adherence will be assessed with a questionnaire | 6 months | No |
| Primary | 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. | 6 months | No |
| Secondary | Drugs adverese effects | Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered. | 6 months | Yes |