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

Primary Purpose

Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dasatinib (BMS-354825)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Leukemia, Lymphoma, Dasatinib, BMS-354825

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives. New York Heart Association (NYHA) Class < 3 Patients must sign informed consent. Exclusion Criteria: 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]).

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dasatinib

Arm Description

Dasatinib 50mg Orally twice daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2006
Last Updated
March 31, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00364286
Brief Title
Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Official Title
Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dasatinib is designed to interfere with a type of protein that appears to be important for the survival of CLL cells. If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day. You will be instructed to take dasatinib in the morning and in the evening. You will have an electrocardiogram (ECG-a test of the electrical activity of your heart) and a physical exam once every 3 months while on study. Blood (about 2-3 teaspoons) will be drawn for routine tests once a week for 1 month and then once a month for the rest of your treatment on this study. A bone marrow biopsy and aspiration will be performed, as needed, to check the status of the disease. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Dasatinib will be given for as long as you are responding. You will be taken off study if the disease gets worse or intolerable side effects occur. This is an investigational study. Dasatinib is not FDA-approved for CLL, and it has been authorized for use in research only. Up to 25 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson. Optional Procedures: If you agree, blood samples (about 2 tablespoons each time) will be collected before therapy starts, at 3-4 hours after the first dose, and at 3 months on therapy. These blood draws will be done when other routine tests are done. No additional needle sticks will be needed. The blood will be used to see how the disease is responding to the drug. You do not have to agree to take part in the optional procedures in order to receive treatment on this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Leukemia, Lymphoma, Dasatinib, BMS-354825

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Experimental
Arm Description
Dasatinib 50mg Orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Dasatinib (BMS-354825)
Other Intervention Name(s)
Dasatinib, SPRYCEL ™
Intervention Description
50mg Orally twice daily
Primary Outcome Measure Information:
Title
Participants With Objective Response
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives. New York Heart Association (NYHA) Class < 3 Patients must sign informed consent. Exclusion Criteria: 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]).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan O'Brien, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://mdanderson.org
Description
UT M.D. Anderson's Website

Learn more about this trial

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

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