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Status unknownNCT03216070Updated Jul 13, 2017

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

A Phase 4 interventional study of Dasatinib 50 MG in Chronic Myelogenous Leukemia, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Status unknown at 1 site in Mexico. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Apr 2016, registered Jul 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
16 Years and older
Sex
Female
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Study 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 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.

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Conditions studied

  • Chronic Myelogenous Leukemia

Keywords

  • Dasatinib
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Arm1 Low Dose Dasatinib

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

    Drug: Dasatinib 50 MG

Interventions

  • DrugDasatinib 50 MG

    50mg of dasatinib orally daily

    Also known as: Sprycel

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What researchers measure

Primary outcomes

  1. Molecular Response at 6 months

    Molecular Response define as BCR/ABL \<1%

    Time frame: 6 months

Secondary outcomes

  1. Early Molecular Response at 3 and 6 months

    Early Molecular Response define as \<10%

    Time frame: 3 and 6 months

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Study locations

1 of 1 sites recruiting
  • Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
    Monterrey, Nuevo Leon 64460, Mexico
    Recruiting
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References and documents

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 27784993 ↗
  • 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. PubMed 20685492 ↗
  • 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. PubMed 16740718 ↗
  • 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. PubMed 20525995 ↗
  • 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. PubMed 18541900 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03216070
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Responsible party
Dra. Olga Graciela Cantu Rodriguez (MD, Hospital Universitario Dr. Jose E. Gonzalez) — Principal investigator
First posted
Jul 13, 2017
Start date
Apr 1, 2016
Primary completion
Oct 1, 2018 (estimated)
Completion
Oct 1, 2018 (estimated)
Last update
Jul 13, 2017

Study contacts

David Gomez, MD
Contact
dr_gomez@infosel.net.mx
52 81 8348-8510

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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