Chronic Myeloid Leukemia, Chronic Phase Clinical Trial
Official title:
Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia
This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. Researchers will describe response rates and adverse events.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | November 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age >18 years 2. Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016 3. Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: 1. Chronic heart disease (NYHA III-IV) 2. Bleeding disorders not attributed to the hematological malignancy 3. Pregnancy 4. Lactation 5. Chronic myeloid leukemia in blast phase 6. Organic dysfunction (Marshall score =2) |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario Dr. José Eleuterio González | Monterrey | Nuevo Leon |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez | Fernando De la Garza Salazar |
Mexico,
Hochhaus A, Saussele S, Rosti G, Mahon FX, Janssen JJWM, Hjorth-Hansen H, Richter J, Buske C; ESMO Guidelines Committee. Chronic myeloid leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv41-iv51. doi: 10.1093/annonc/mdx219. No abstract available. Erratum In: Ann Oncol. 2018 Oct 1;29(Suppl 4):iv261. — View Citation
Johnson FM, Agrawal S, Burris H, Rosen L, Dhillon N, Hong D, Blackwood-Chirchir A, Luo FR, Sy O, Kaul S, Chiappori AA. Phase 1 pharmacokinetic and drug-interaction study of dasatinib in patients with advanced solid tumors. Cancer. 2010 Mar 15;116(6):1582-91. doi: 10.1002/cncr.24927. — View Citation
Naqvi K, Jabbour E, Skinner J, Anderson K, Dellasala S, Yilmaz M, Ferrajoli A, Bose P, Thompson P, Alvarado Y, Jain N, Takahashi K, Burger J, Estrov Z, Borthakur G, Pemmaraju N, Paul S, Cortes J, Kantarjian HM. Long-term follow-up of lower dose dasatinib (50 mg daily) as frontline therapy in newly diagnosed chronic-phase chronic myeloid leukemia. Cancer. 2020 Jan 1;126(1):67-75. doi: 10.1002/cncr.32504. Epub 2019 Sep 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of Complete Cytogenetic Response | B-cell antigen receptor(BCR)/Tyrosine-protein kinase-ABL1(ABL1) IS <=1% at 6 months | Up to 6 months | |
Secondary | The rate of Molecular Response (MR4) | Log reduction in BCR/ABL of 4 | Up to 6 months | |
Secondary | The rate of Molecular Response (MR4.5) | Log reduction in BCR/ABL of 4.5 | Up to 6 months | |
Secondary | The rate of sustained Molecular Response (MR4.5) | Log reduction in BCR/ABL of 4.5 | Up to 12 months | |
Secondary | The proportion of non hematological side effects | Proportion of patients that presented non hematological side effects to the intervention | Up to 12 months | |
Secondary | The rate of Complete Cytogenetic Response | BCR/ABL IS <=1% at 12 months | Up to 12 months |
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