Low-dose Dasatinib as First-line Treatment for Chronic My... | NCT03216070

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

NCT03216070

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Status

Unknown status

Last Update Posted

Jul 13, 2017Actual

Enrollment

12Estimated

Phase

Phase 4

Conditions

Chronic Myelogenous Leukemia

Interventions

Dasatinib 50 MG

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Oct 1, 2018Estimated

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2017

Last Update Posted Date

Jul 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dra. Olga Graciela Cantu Rodriguez, MD, Hospital Universitario Dr. Jose E. GonzalezPrincipal Investigator

Lead Sponsor

Hospital Universitario Dr. Jose E. GonzalezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm1 Low Dose Dasatinib	Experimental	We will give 50mg of dasatinib orally daily for 6 months	Drug: Dasatinib 50 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dasatinib 50 MG	Drug	50mg of dasatinib orally daily	Arm1 Low Dose Dasatinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Molecular Response at 6 months	Molecular Response define as BCR/ABL <1%	6 months

Secondary Outcomes

Measure	Description	Time Frame
Early Molecular Response at 3 and 6 months	Early Molecular Response define as <10%	3 and 6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Gomez, MD	Contact	52 81 8348-8510		dr_gomez@infosel.net.mx

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer	Recruiting	Monterrey	Nuevo León	64460	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27784993	Background	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.
20685492	Background	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.

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles