Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
PRIMARY OBJECTIVE:
I. To assess incidence of major molecular response (MMR) at 12 months.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 12 and 24 months.
II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12 and 24 months.
III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.
IV. To assess safety.
V. To assess patient reported outcomes (PRO).
TERTIARY OBJECTIVES:
I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow.
II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (TKIs) discontinuation trials.
OUTLINE:
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
After completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.
Age
17–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization \[WHO\] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications
Able to give written informed consent and comply with all study visits and procedures
You may not be if
Chronic myeloid leukemia (CML) in AP or BP
Unable to receive TKI for insurance reasons (uninsurable)
Refuse or unable to perform telephone or video conferences with research coordinator
Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
Clareo Health | Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
