Dasatinib in Relapsed Chronic Lymphocytic Leukemia

NCT ID: NCT00438854

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2013-03-31

Brief Summary

The purpose of this research study is to see if Dasatinib is effective and safe to give to people with relapsed chronic lymphocytic leukemia (CLL) and to determine the effects of the drug on LYN kinase activity in blood and bone marrow. Recent research shows that a key enzyme in CLL cells is responsible for cell survival. This enzyme is called LYN kinase. Laboratory studies show that inhibition of LYN kinase in CLL cells results in the death to CLL cells. Dasatinib has the ability to inhibit LYN kinase and, therefore, should have some effect on CLL cells.

Detailed Description

• After the screening procedures confirm that the participant is eligible and willing to participate in the research study, they will have the following tests and procedures.
• Dasatinib is given orally once daily. Each participant will have a pill diary to record doses and any missed doses. All necessary drug refills will be given during clinic appointments, at which time the pill diary and any unused study drug will be returned.
• During the first month of study treatment the participant will come to the clinic at the following intervals: Day 1: An EKG will be performed two hours after the first dose of medication; Days 3-8: Blood samples will be drawn once between days 3-8; Weeks 2-4: A physical examination, EKG and blood samples will be drawn once a week.
• Beginning with the second month of study treatment, participants will come to the clinic monthly for up to two years. The following tests and procedures will be done; physical examination (monthly), blood work (monthly), pregnancy test (monthly), EKG (monthly for 6 months, then when medically indicated), CT of the neck, chest and abdomen (every 2 months for 6 months, then once every 6 months), at the end of month 2, additional blood will be drawn for research testing.
• Participants can continue to take the study drug for up to two years as long as their disease does not progress and they are not experiencing any serious side effects.

Conditions

Chronic Lymphocytic Leukemia

Keywords

dasatinib; BMS-354825; CLL; SLL; LYN kinase

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib treatment

All patients were treated with dasatinib pills by mouth as treatment.

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.

Interventions

Dasatinib

Taken orally once daily. Participants may continue on study treatment as long as there is no disease progression or serious side effects.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23 and CD. Patients may be CD23 negative as long as they are also cyclin D1 negative.
• Must have failed at least 1 prior fludarabine containing regimen or have failed at least 2 non-fludarabine containing regimens or have a contraindication to fludarabine use
• ECOG performance status of 2 or better
• Adequate organ function to tolerate chemotherapy
• Adequate method of contraception

Exclusion Criteria

• Pregnant or breast-feeding women
• Uncontrolled angina within 3 months
• Diagnosed or suspected congenital long QT syndrome
• History of clinically significant ventricular arrhythmias
• Prolonged QTc interval on pre-entry electrocardiogram
• Uncontrolled hypertension
• Drugs that are generally accepted to have a risk of causing Torsades de Pointes
• Patient known to be HIV positive
• Known significant bleeding disorder unrelated to CLL
• Drugs that interfere with platelet function or coagulation must be stopped at least 7 days prior to entry

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

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Philip C. Amrein, M.D.

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Amrein, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

CA 180-045

Identifier Type: -

Identifier Source: secondary_id

06-211

Identifier Type: -

Identifier Source: org_study_id