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


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

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


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bone is withdrawn through a large needle.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.


Inclusion Criteria:



1. Diagnosis of CLL, Small lymphocytic lymphoma (SLL), or -cell prolymphocytic leukemia
(T-PLL).

2. Previously treated with chemotherapy or monoclonal antibodies.

3. 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.

4. Serum bilirubin less than 2mg/dL, serum creatinine less than 2mg/dL unless
abnormality is considered due to CLL by investigator.

5. The Eastern Cooperative Oncology Group (ECOG) Performance Status < 3.

6. 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.

7. 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.

8. 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.

9. New York Heart Association (NYHA) Class < 3

10. Patients must sign informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding women are excluded.

2. 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.

3. Patients must not have untreated or uncontrolled life-threatening infection.

4. 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.

5. 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]).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

Number of participants with a response (Complete Response or Partial Response) out of total participants. Responses evaluated every 3 months +/- 1 week by each component and overall by NCI criteria.

Outcome Time Frame:

4 week treatment cycle

Safety Issue:

No

Principal Investigator

Susan O'Brien, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2005-0497

NCT ID:

NCT00364286

Start Date:

August 2006

Completion Date:

November 2012

Related Keywords:

  • Leukemia
  • Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Prolymphocytic Leukemia
  • Leukemia
  • Lymphoma
  • Dasatinib
  • BMS-354825
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030