Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Chronic Phase Chronic Myeloid Leukemia Clinical Trial

Official title:
A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Status Completed

Clinical Trial Summary

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Chronic Phase Chronic Myeloid Leukemia
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase

Clinical Trial Details

NCT number	NCT01660906
Study type	Interventional
Source	Bristol-Myers Squibb
Contact
Status	Completed
Phase	Phase 4
Start date	December 2012
Completion date	October 2015

View Details

See also
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Completed	`NCT03045120` - Determining Change in Cardiovascular and Metabolic Risks in Patients With Chronic Phase Chronic Myeloid Leukemia Receiving BCR-ABL Tyrosine Kinase Inhibitor First-Line Therapy in the United States
Recruiting	`NCT03934372` - Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors	Phase 1/Phase 2
Completed	`NCT01850004` - Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response	Phase 2
Completed	`NCT01702064` - Ruxolitinib in Combination With Nilotinib in Chronic Myeloid Leukemia (CML) Patients	Phase 1
Terminated	`NCT02627677` - A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia	Phase 3
Completed	`NCT01933906` - Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response	Phase 1
Completed	`NCT01914484` - Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia	Phase 1/Phase 2