NCT02709083

Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia

First-Line Dasatinib or Nilotinib Followed by Response Guided Switch to Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well dasatinib, nilotinib, and imatinib mesylate works in treating patients with newly diagnosed, previously untreated chronic myeloid leukemia in which fewer than 10% of the cells in the blood and bone marrow are blast cells (immature blood cells) (chronic phase). Dasatinib, nilotinib, and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed description

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.

Conditions

• Chronic Myelogenous Leukemia
• Chronic Myeloid Leukemia
• Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Given orally
DRUG	Imatinib Mesylate	Given orally
DRUG	Nilotinib	Given orally

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-03-15
• Last updated: 2018-11-02
• Results posted: 2018-11-02

Locations

1 site across 1 country: United States