Dasatinib in Relapsed Chronic Lymphocytic Leukemia

NCT00438854 | Completed Phase 2 Results

• 2 other identifiers: 06-211CA 180-045
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response

  Overall objective response rate in terms of complete response, nodular partial response, and partial response to treatment. Objective response is when a biopsy shows. In general response is defined as the following (not complete criteria): Complete response (CR) requires all of the following for a period of at least 2 months: * Absence of lymphadenopathy * No hepatomegaly or splenomegaly * Absence of constitutional symptoms * Normal complete blood count Nodular partial response (nPR): Met the criteria for CR, but had residual bone marrow biopsy nodules as the only evidence of disease Partial response (PR): requires at least the following: * 50% decrease in peripheral blood lymphocyte count * 50% reduction in lymphadenopathy * 50% reduction in the size of the liver and/or spleen

  2 years

Secondary Outcomes (3)

• Complete Response Rate

  1 year

• Median Time to Disease Progression

  1 year

• Median Overall Survival

  3 years

Study Arms (1)

Dasatinib treatment

EXPERIMENTAL

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

Drug: Dasatinib

Interventions

Dasatinib DRUG

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

Dasatinib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Dana-Farber Cancer Institute: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Philip C. Amrein, M.D.
• Organization: Massachusetts General Hospital

pamrein@partners.org

617-726-8748

Study Officials

• Philip Amrein, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: December 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2013
• Last Updated: December 13, 2017
• Results First Posted: October 12, 2012

Record last verified: 2017-11

Locations

US (2)