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Trial Title:
Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia
NCT ID:
NCT05638763
Condition:
Chronic Myeloid Leukemia, Chronic Phase
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Ketoconazole
Dasatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dasatinib Pill
Description:
Patients will receive half pill of dasatinib 50mg (25mg/day, orally) for one year
Arm group label:
Dasatinib and ketoconazole
Other name:
Sprycel
Intervention type:
Drug
Intervention name:
Ketoconazole Pill
Description:
Patients will receive ketoconazole 200mg two times a day, orally, for one year.
Arm group label:
Dasatinib and ketoconazole
Other name:
Nizoral
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario Dr. José Eleuterio González
Address:
City:
Monterrey
Zip:
64630
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Dr Fernando De la Garza Salazar, MD
Phone:
8442322102
Email:
fernandodelagarza@gmail.com
Contact backup:
Last name:
Fernando De la Garza Salazar, MD
Phone:
8442322102
Start date:
November 2024
Completion date:
November 2024
Lead sponsor:
Agency:
Hospital Universitario Dr. Jose E. Gonzalez
Agency class:
Other
Collaborator:
Agency:
Fernando De la Garza Salazar
Agency class:
Other
Source:
Hospital Universitario Dr. Jose E. Gonzalez
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638763
