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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05638763
Other study ID # HE22-00031
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 2024
Est. completion date November 2024

Study information

Verified date November 2022
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact Fernando De la Garza Salazar, MD
Phone (52) 811 080 2131
Email fernandodelagarza@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Dasatinib is a second-generation tyrosine kinase inhibitor that is metabolized by the cytochrome P450. Dasatinib has shown efficacy in patients with chronic myelogenous leukemia. Standard-dose dasatinib is 50mg-140mg/day orally, continuously. However, when combined with a strong CYP3A4 inhibitor, a dose reduction of 75% is warranted. 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Mexico Hospital Universitario Dr. José Eleuterio González Monterrey Nuevo Leon

Sponsors (2)

Lead Sponsor Collaborator
Hospital Universitario Dr. Jose E. Gonzalez Fernando De la Garza Salazar

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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

Outcome

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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