Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

NCT ID: NCT03625388

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2023-07-22

Brief Summary

The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)

Detailed Description

A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months

Conditions

Chronic Myelogenous Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib 50 mg

Dasatinib 50 mg orally once daily

Group Type: OTHER

Dasatinib

Intervention Type: DRUG

Film coated tablet contains dasatinib monohydrate

Dasatinib 100 mg

Dasatinib 100 mg orally once daily

Group Type: OTHER

Dasatinib

Intervention Type: DRUG

Film coated tablet contains dasatinib monohydrate

Interventions

Dasatinib

Film coated tablet contains dasatinib monohydrate

Intervention Type: DRUG

Other Intervention Names

Elpida®

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Diagnosis of Ph+ or BCR-ABL positive CML in early CP (i.e. time from diagnosis <12 months). Except for hydroxyurea and/or 1-2 doses of cytarabine (up to 6g/m2 total), patients must have received no or minimal prior therapy, defined as 30 days of prior approved tyrosine kinase inhibitor (TKI).

3. Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph-chromosome has been historically included as a criterion of accelerated phase (AP). However, patients with clonal evolution as the only criterion of AP have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for AP will be eligible for this study.

4. ECOG performance of 0-2.

5. Adequate end organ function defined as the following: total bilirubin <1.5x ULN (unless secondary to Gilbert's disease, in which case it should be <2.5x ULN), SGPT <2.5x ULN, creatinine <1.5x ULN.

6. Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital

Exclusion Criteria

1. NYHA cardiac class 3-4 heart disease

2. Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:

1. Uncontrolled angina within 3 months

2. Diagnosed or suspected congenital long QT syndrome

3. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)

4. Prolonged QTc interval on pre-entry electrocardiogram (>460 msec)

3. History of significant bleeding disorder unrelated to cancer including:

1. Diagnosed congenital bleeding disorders (e.g. Von Willebrand's disease)

2. Diagnosed acquired bleeding disorder within one year (e.g. acquired anti-factor VIII antibodies)

3. Isolated thrombocytopenia without recurrent bleeding episodes shall be considered eligible for study entry

4. Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders

5. Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized

1. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy

2. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential

3. Women must continue birth control for the duration of the study and at least 3 months after the last dose of study drug

6. Pregnant or breast-feeding women are excluded

a. All WOCBP must have a negative pregnancy test prior to first receiving the study drug. If the pregnancy test is positive, the patient must not receive the study drug and must not be enrolled in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King Hussein Cancer Center (KHCC)

Amman, , Jordan

Jordan University Hospital (JUH)

Amman, , Jordan

American University of Beirut Medical Center (AUBMC)

Beirut, , Lebanon

The King Faisal Specialist Hospital and Research Centre (KFSH&RC)

Riyadh, , Saudi Arabia

Aziza Othmana Hospital

Tunis, , Tunisia

Countries

Jordan; Lebanon; Saudi Arabia; Tunisia

Other Identifiers

LPI-JOR-LEB-KSA-TUN-2017-01

Identifier Type: -

Identifier Source: org_study_id