Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia
NCT ID: NCT05638763
Last Updated: 2022-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2024-11-30
2024-11-30
Brief Summary
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Detailed Description
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This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce the dosage and costs of dasatinib for adults with chronic myelogenous leukemia. Researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months and adverse events (i.e., pleural effusion) associated with this strategy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dasatinib and ketoconazole
Patients will receive dasatinib at a dose of 25mg orally daily for one year and ketoconazole 200mg orally two times per day for one year.
Dasatinib Pill
Patients will receive half pill of dasatinib 50mg (25mg/day, orally) for one year
Ketoconazole Pill
Patients will receive ketoconazole 200mg two times a day, orally, for one year.
Interventions
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Dasatinib Pill
Patients will receive half pill of dasatinib 50mg (25mg/day, orally) for one year
Ketoconazole Pill
Patients will receive ketoconazole 200mg two times a day, orally, for one year.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016
3. Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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Fernando De la Garza Salazar
UNKNOWN
Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
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David Gomez Almaguer
Head of Department
Locations
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Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
Countries
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Central Contacts
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Facility Contacts
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Fernando De la Garza Salazar, MD
Role: backup
References
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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.
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.
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.
Other Identifiers
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HE22-00031
Identifier Type: -
Identifier Source: org_study_id
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