Radotinib as 3rd or Later Line Therapy in CP-CML (REVITAL)

Ulsan University Hospital

Status and phase: Unknown; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Radotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02422719

RAD-201501

Details and patient eligibility

About

The purpose of this study is to determine whether radotinib is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors.

Full description

The purpose of this study is to determine whether radotinib 400mg bid is effective and safe for patients with chronic myeloid leukemia, chronic phase who are intolerable or resistant to prior 2 or more tyrosine kinase inhibitors. The primary end point is major cytogenetic response by 12 months.

Enrollment: 73 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic myeloid leukemia chronic phase (CP-CML) patients who are not tolerable or resistant to prior 2 or more tyrosine kinase inhibitors (TKIs).
• ECOG 0, 1, 2
• Patients who are agree and signed to informed consent.

Exclusion criteria

• T315I mutation
• Prior exposure to radotinib
• Accelerated or blastic phase
• galactose intolerance, severe lactase deficiency or glucose galactose malabsorption
• Prior history of intensive cytotoxic chemotherapy except for TKIs
• Significant cardiac problem
• QTcF > 450 msec
• Pancreatitis history prior to study enrollment
• Clinically significant malignant disease other than CML
• Pregnant or breast feeding woman

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Radotinib

Experimental group

Description:

Radotinib treatement single arm

Treatment:

Drug: Radotinib