NCT03216070

Brief 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.

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
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2016

Typical duration for phase_4

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

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

July 10, 2017

Last Update Submit

July 10, 2017

Conditions

Chronic Myelogenous Leukemia

Keywords

Dasatinib

Outcome Measures

Primary Outcomes (1)

  • Molecular Response at 6 months

    Molecular Response define as BCR/ABL \<1%

    6 months

Secondary Outcomes (1)

  • Early Molecular Response at 3 and 6 months

    3 and 6 months

Study Arms (1)

Arm1 Low Dose Dasatinib

EXPERIMENTAL

We will give 50mg of dasatinib orally daily for 6 months

Drug: Dasatinib 50 MG

Interventions

Dasatinib 50 MGDRUG

50mg of dasatinib orally daily

Also known as: Sprycel
Arm1 Low Dose Dasatinib

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • NYHA cardiac class 3-4 heart disease or previous pleural effusion.
  • Pregnancy and lactation
  • Patients with active, uncontrolled psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27784993BACKGROUND

  • 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.

    PMID: 20685492BACKGROUND

  • 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. doi: 10.1158/0008-5472.CAN-05-4187.

    PMID: 16740718BACKGROUND

  • Kantarjian 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.

    PMID: 20525995BACKGROUND

  • Shah 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.

    PMID: 18541900BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, 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 CompoundsPyrimidines

Central Study Contacts

David Gomez, MD

CONTACT

52 81 8348-8510dr_gomez@infosel.net.mx

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 10, 2017

First Posted

July 13, 2017

Study Start

April 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)