Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)

NCT00364286 | Completed Phase 2 Results

• 2 other identifiers: 2005-0497NCI-2012-01562
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if dasatinib can help to control Chronic Lymphocytic Leukemia (CLL). The safety of the drug will also be studied. Optional Procedures: You will be asked to have additional blood samples drawn. These samples will be used to see how the disease is responding to the drug.

Conditions

Lymphoma; Leukemia

Keywords

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Prolymphocytic Leukemia; Leukemia; Lymphoma; Dasatinib; BMS-354825

Outcome Measures

Primary Outcomes (1)

• Participants With Objective Response

  Number of participants with an Objective Response defined as Complete Response (CR) or Partial Response (PR). Responses evaluated every 3 months +/- 1 week by each component and overall by National Cancer Institute Working Group (NCIWG) criteria where Response judged, Nodes for CR: None; PR: \> 50% decrease; Liver/Spleen CR: Not palpable; PR: \> 50% decrease; Symptoms for CR: None; PR: Not applicable (N/A); polymorphonuclear leukocyte (PMN) for CR: \>1,500/μl, PR: \> 1,500/μl or \>50% improvement from baseline; Platelets for CR: \>100,000/μl, PR: \>100,000/μl or \> 50% improvement from baseline; Hemoglobin (untransfused) for CR: \>11,0 g/dl; PR: \>11.0 g/dl or \>50% improvement from baseline; Lymphocytes for CR: \<4,000/μl and PR: \>50% decrease; Bone Marrow aspirate for CR: \<30% lymphocytes, N/A for PR; Bone Biopsy for CR: No lymphocyte infiltrate; PR: \< 30% lymphocytes with residual disease on biopsy for nodular PR.

  up to 3 months

Study Arms (1)

Dasatinib

EXPERIMENTAL

Dasatinib 50mg Orally twice daily.

Drug: Dasatinib (BMS-354825)

Interventions

Dasatinib (BMS-354825) DRUG

50mg Orally twice daily

Also known as: Dasatinib, SPRYCEL ™

Dasatinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CLL, Small lymphocytic lymphoma (SLL), or -cell prolymphocytic leukemia (T-PLL).
• Previously treated with chemotherapy or monoclonal antibodies.
• All patients with Rai stage III-IV are eligible. - OR - Patients with Rai stage 0-II who meet one or more indication for treatment as defined by the NCI-sponsored Working Group are eligible:Massive or progressive splenomegaly; Massive lymph nodes, nodal clusters, or progressive lymphadenopathy; Grade 2 or 3 fatigue, fever \>/= 100.5 degrees F, night sweats for \> 2 weeks w/o documented infection, presence of weight loss \>/= 10% over the preceding 6 months; Progressive lymphocytosis with increase in lymphocyte count of \>/= 50% over a 2-month period or an anticipated doubling time of \< 6 months.
• Serum bilirubin less than 2mg/dL, serum creatinine less than 2mg/dL unless abnormality is considered due to CLL by investigator.
• The Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3.
• Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
• Sexually active women of childbearing potential must use birth control during study in manner that risk of failure is minimized. Prior to study enrollment women of childbearing potential must be advised of importance of avoiding pregnancy during trial and potential risk factors for unintentional pregnancy. MUST have negative pregnancy test. If pregnancy test is positive patient must not receive investigational product and must not be enrolled in study. Men enrolled on study should understand risks to sexual partner of childbearing potential and practice effective birth control.
• New York Heart Association (NYHA) Class \< 3
• Patients must sign informed consent.

You may not qualify if:

• Pregnant or breast-feeding women are excluded.
• Patients may not receive concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply, nor do hematopoietic growth factors such as erythropoietin, G-CSF, GM-CSF etc.
• Patients must not have untreated or uncontrolled life-threatening infection.
• Uncontrolled angina within 3 months; diagnosed or suspected congenital long QT syndrome; any history of clinically significant ventricular arrhythmias; prolonged QTc interval (\> 450 msec); uncontrolled hypertension; significant bleeding disorder unrelated to cancer; patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes.
• Medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) or Anticoagulants (warfarin, heparin/low molecular weight heparin \[e.g., danaparoid, dalteparin, tinzaparin, enoxaparin\]).

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT M.D. Anderson's Website

MeSH Terms

Conditions

Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Prolymphocytic

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; 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: Susan O'Brien, MD/ Professor
• Organization: The University of Texas MD Anderson Cancer Center

eharriso@mdanderson.org

713-792-7543

Study Officials

• Susan O'Brien, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 20, 2026
• Results First Posted: August 21, 2013

Record last verified: 2025-12

Locations

US (1)