Clinical trial · Interventional
Low-dose Dasatinib as First-line Treatment for Chronic Myeloid Leukemia
NCT03216070CI-TRIAL-00028621unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib 50 MG | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm1 Low Dose Dasatinib
- description
- We will give 50mg of dasatinib orally daily for 6 months
- interventionNames
- Drug: Dasatinib 50 MG
Primary outcomes (1)
- measure
- Molecular Response at 6 months
- timeFrame
- 6 months
- description
- Molecular Response define as BCR/ABL \<1%
Secondary outcomes (1)
- measure
- Early Molecular Response at 3 and 6 months
- timeFrame
- 3 and 6 months
- description
- Early Molecular Response define as \<10%
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDKeskin 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 27784993
- BACKGROUNDStein 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 20685492
- BACKGROUNDTokarski 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 16740718
- BACKGROUNDKantarjian 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 20525995
- BACKGROUNDShah 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 18541900