Chronic Myelogenous LeukemiaPhase 4NCT03216070
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
A Phase 4 study testing Dasatinib 50 MG in people with Chronic Myelogenous Leukemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- Dasatinib 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2016to 1 Oct 2018
- Phase
- Phase 4
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <2 weeks (14 days) of prior FDA approved TKI.
- ECOG performance of 0-2
- Adequate end organ function, defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- Patients must sign an informed consent indicating they are aware of the investigational nature of this study.
Who cannot join
- NYHA cardiac class 3-4 heart disease or previous pleural effusion.
- Pregnancy and lactation
- Patients with active, uncontrolled psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo León, 64460
David Gomez-Almaguer, MD, +52 81 8348-8510, dr_gomez@infosel.net.mx
Paola Santana, MD, +52 664 3864975, paola_santana72@hotmail.com
About this study
Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.
Read the detailed description
We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a BCR/ABL PCR will be taken to evaluate molecular response.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- Dasatinib 50 MG
- Keywords
- Dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib 50 MGDrug
Also called Sprycel
50mg of dasatinib orally daily
| Study group | Role | What they receive |
|---|---|---|
| Arm1 Low Dose Dasatinib | Experimental | We will give 50mg of dasatinib orally daily for 6 months Receives: Drug: Dasatinib 50 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Response at 6 months
Molecular Response define as BCR/ABL <1%
Measured: 6 months
Secondary outcomes (1)
Early Molecular Response at 3 and 6 months
Early Molecular Response define as <10%
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Apr 2016
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra. Olga Graciela Cantu Rodriguez, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216070
- Sponsor's protocol ID
- HE17 00004
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keskin D, Sadri S, Eskazan AE. Dasatinib for the treatment of chronic myeloid leukemia: patient selection and special considerations. Drug Des Devel Ther. 2016 Oct 13;10:3355-3361. doi: 10.2147/DDDT.S85050. eCollection 2016.
PubMed 27784993Stein B, Smith BD. Treatment options for patients with chronic myeloid leukemia who are resistant to or unable to tolerate imatinib. Clin Ther. 2010 May;32(5):804-20. doi: 10.1016/j.clinthera.2010.05.003.
PubMed 20685492Tokarski JS, Newitt JA, Chang CY, Cheng JD, Wittekind M, Kiefer SE, Kish K, Lee FY, Borzillerri R, Lombardo LJ, Xie D, Zhang Y, Klei HE. The structure of Dasatinib (BMS-354825) bound to activated ABL kinase domain elucidates its inhibitory activity against imatinib-resistant ABL mutants. Cancer Res. 2006 Jun 1;66(11):5790-7. doi: 10.1158/0008-5472.CAN-05-4187.
PubMed 16740718Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.
PubMed 20525995Shah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.
PubMed 18541900
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03216070
- Acronym / sponsor ID
- HE17 00004
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Dasatinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in CML.
Detailed description
We will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a BCR/ABL PCR will be taken to evaluate molecular response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 Low Dose Dasatinib | Experimental | Drug: Dasatinib 50 MGWe will give 50mg of dasatinib orally daily for 6 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of BCR-ABL positive CML in early chronic phase CML. Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <2 weeks (14 days) of prior FDA approved TKI.
- ECOG performance of 0-2
- Adequate end organ function, defined as the following: total bilirubin <1.5x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- Patients must sign an informed consent indicating they are aware of the investigational nature of this study.
Key exclusion criteria (3 listed)
- NYHA cardiac class 3-4 heart disease or previous pleural effusion.
- Pregnancy and lactation
- Patients with active, uncontrolled psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib 50 MGAlso: Sprycel50mg of dasatinib orally daily | Drug | Arm1 Low Dose Dasatinib |
Primary outcome
Molecular Response at 6 months
Time frame: 6 months
Molecular Response define as BCR/ABL <1%
1 secondary outcome
Early Molecular Response at 3 and 6 months
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Background: PubMed 27784993Keskin D, Sadri S, Eskazan AE. Dasatinib for the treatment of chronic myeloid leukemia: patient selection and special considerations. Drug Des Devel Ther. 2016 Oct 13;10:3355-3361. doi: 10.2147/DDDT.S85050. eCollection 2016.
- Background: PubMed 20685492Stein B, Smith BD. Treatment options for patients with chronic myeloid leukemia who are resistant to or unable to tolerate imatinib. Clin Ther. 2010 May;32(5):804-20. doi: 10.1016/j.clinthera.2010.05.003.
- Background: PubMed 16740718Tokarski JS, Newitt JA, Chang CY, Cheng JD, Wittekind M, Kiefer SE, Kish K, Lee FY, Borzillerri R, Lombardo LJ, Xie D, Zhang Y, Klei HE. The structure of Dasatinib (BMS-354825) bound to activated ABL kinase domain elucidates its inhibitory activity against imatinib-resistant ABL mutants. Cancer Res. 2006 Jun 1;66(11):5790-7. doi: 10.1158/0008-5472.CAN-05-4187.
- Background: PubMed 20525995Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.
- Background: PubMed 18541900Shah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dasatinib 50 MG in people with Chronic Myelogenous Leukemia, 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 4 inclusion and 3 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 13 Jul 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 David Gomez, MD (52 81 8348-8510, dr_gomez@infosel.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Response at 6 months (time frame: 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 NCT03216070, which also lists 5 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 13 Jul 2017.