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Chronic Myeloid Leukemia, Chronic PhasePhase 2NCT05638763

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

A Phase 2 study testing Dasatinib Pill and Ketoconazole Pill in people with Chronic Myeloid Leukemia, Chronic Phase, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia, Chronic Phase
What is being tested?
Dasatinib Pill and Ketoconazole Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteMexico
Study dates
Nov 2024to Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Fernando De la Garza Salazar, MD contact

(52) 811 080 2131

fernandodelagarza@gmail.com

Mexico1 site, 1 recruiting

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey, Nuevo León, 64630

    Dr Fernando De la Garza Salazar, MD, 8442322102, fernandodelagarza@gmail.com

    Fernando De la Garza Salazar, MD, 8442322102

    Recruiting

Other trials in Mexico

About this study

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.

Read the 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.

Being tested
Dasatinib Pill, Ketoconazole Pill
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dasatinib PillDrug

    Also called Sprycel

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

  • Ketoconazole PillDrug

    Also called Nizoral

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

Study groups in NCT05638763
Study groupRoleWhat they receive
Dasatinib and ketoconazoleExperimentalPatients will receive dasatinib at a dose of 25mg orally daily for one year and ketoconazole 200mg orally two times per day for one year.
Receives: Drug: Dasatinib Pill; Drug: Ketoconazole Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of Complete Cytogenetic Response

    B-cell antigen receptor(BCR)/Tyrosine-protein kinase-ABL1(ABL1) IS <=1% at 6 months

    Measured: Up to 6 months

Secondary outcomes (5)

  1. The rate of Molecular Response (MR4)

    Log reduction in BCR/ABL of 4

    Measured: Up to 6 months

  2. The rate of Molecular Response (MR4.5)

    Log reduction in BCR/ABL of 4.5

    Measured: Up to 6 months

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

    Log reduction in BCR/ABL of 4.5

    Measured: Up to 12 months

  4. The proportion of non hematological side effects

    Proportion of patients that presented non hematological side effects to the intervention

    Measured: Up to 12 months

  5. The rate of Complete Cytogenetic Response

    BCR/ABL IS <=1% at 12 months

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study startNov 2024 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05638763
Sponsor's protocol ID
HE22-00031
Status last verified
Nov 2022
First submitted
16 Nov 2022
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28881915

  • 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.

    PubMed 20108303

  • 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.

    PubMed 31553487

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib Pill and Ketoconazole Pill in people with Chronic Myeloid Leukemia, Chronic Phase, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fernando De la Garza Salazar, MD ((52) 811 080 2131, fernandodelagarza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of Complete Cytogenetic Response (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05638763, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.

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