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

Primary Purpose

Chronic Myelogenous Leukemia

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Dasatinib 50 MG
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Dasatinib

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el CancerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm1 Low Dose Dasatinib

Arm Description

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

Outcomes

Primary Outcome Measures

Molecular Response at 6 months
Molecular Response define as BCR/ABL <1%

Secondary Outcome Measures

Early Molecular Response at 3 and 6 months
Early Molecular Response define as <10%

Full Information

First Posted
July 10, 2017
Last Updated
July 10, 2017
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT03216070
Brief Title
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
Official Title
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
Dasatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm1 Low Dose Dasatinib
Arm Type
Experimental
Arm Description
We will give 50mg of dasatinib orally daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Dasatinib 50 MG
Other Intervention Name(s)
Sprycel
Intervention Description
50mg of dasatinib orally daily
Primary Outcome Measure Information:
Title
Molecular Response at 6 months
Description
Molecular Response define as BCR/ABL <1%
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Early Molecular Response at 3 and 6 months
Description
Early Molecular Response define as <10%
Time Frame
3 and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Gomez, MD
Phone
52 81 8348-8510
Email
dr_gomez@infosel.net.mx
Facility Information:
Facility Name
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gomez-Almaguer, MD
Phone
+52 81 8348-8510
Email
dr_gomez@infosel.net.mx
First Name & Middle Initial & Last Name & Degree
Paola Santana, MD
Phone
+52 664 3864975
Email
paola_santana72@hotmail.com
First Name & Middle Initial & Last Name & Degree
David Gomez-Almaguer, MD
First Name & Middle Initial & Last Name & Degree
Manuel Solano, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27784993
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. doi: 10.2147/DDDT.S85050. eCollection 2016.
Results Reference
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PubMed Identifier
20685492
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.
Results Reference
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PubMed Identifier
16740718
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. doi: 10.1158/0008-5472.CAN-05-4187.
Results Reference
background
PubMed Identifier
20525995
Citation
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.
Results Reference
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PubMed Identifier
18541900
Citation
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.
Results Reference
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Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia

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