NCT05638763

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

Same day

First QC Date

November 16, 2022

Last Update Submit

November 25, 2022

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The rate of Molecular Response (MR4)

    Up to 6 months

  • The rate of Molecular Response (MR4.5)

    Up to 6 months

  • The rate of sustained Molecular Response (MR4.5)

    Up to 12 months

  • The proportion of non hematological side effects

    Up to 12 months

  • The rate of Complete Cytogenetic Response

    Up to 12 months

Study Arms (1)

Dasatinib and ketoconazole

EXPERIMENTAL

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.

Drug: Dasatinib PillDrug: Ketoconazole Pill

Interventions

Dasatinib PillDRUG

Patients will receive half pill of dasatinib 50mg (25mg/day, orally) for one year

Also known as: Sprycel
Dasatinib and ketoconazole
Ketoconazole PillDRUG

Patients will receive ketoconazole 200mg two times a day, orally, for one year.

Also known as: Nizoral
Dasatinib and ketoconazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016
  • Eastern Cooperative Oncology Group (ECOG) 0-2

You may not qualify if:

  • Chronic heart disease (NYHA III-IV)
  • Bleeding disorders not attributed to the hematological malignancy
  • Pregnancy
  • Lactation
  • Chronic myeloid leukemia in blast phase
  • Organic dysfunction (Marshall score ≥2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64630, Mexico

RECRUITING

Related 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.

    PMID: 28881915BACKGROUND

  • 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.

    PMID: 20108303BACKGROUND

  • 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.

    PMID: 31553487BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

DasatinibKetoconazole

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPiperazines

Central Study Contacts

Fernando De la Garza Salazar, MD

CONTACT

(52) 811 080 2131fernandodelagarza@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 6, 2022

Study Start

November 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

December 6, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)