Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Chronic Myelogenous Leukemia Clinical Trial

Official title:

Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216070
• Other study ID #: HE17 00004
• Status: Recruiting
• Phase: Phase 4
• First received: July 10, 2017
• Last updated: July 10, 2017
• Start date: April 1, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: July 2017
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: David Gomez, MD
• Phone: 52 81 8348-8510
• Email: dr_gomez[@]infosel.net.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• NYHA cardiac class 3-4 heart disease or previous pleural effusion.

• Pregnancy and lactation

• Patients with active, uncontrolled psychiatric disorders

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Dasatinib 50 MG
50mg of dasatinib orally daily

Locations

Country	Name	City	State
Mexico	Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boqué 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. — View Citation

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. eCollection 2016. Review. — View Citation

Shah NP, Kantarjian HM, Kim DW, Réa 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. — View Citation

Stein 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. Review. — View Citation

Tokarski 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular Response at 6 months	Molecular Response define as BCR/ABL <1%	6 months
Secondary	Early Molecular Response at 3 and 6 months	Early Molecular Response define as <10%	3 and 6 months