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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00364286
First received: August 14, 2006
Last updated: June 12, 2013
Last verified: June 2013

August 14, 2006
June 12, 2013
August 2006
November 2012   (final data collection date for primary outcome measure)
Participants With Objective Response [ Time Frame: 4 week treatment cycle ] [ Designated as safety issue: No ]
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.
  • CBC weekly x 4; then every 2-4 weeks on study
  • Serum chemistries every 2 weeks x 2 then every month on study
  • Bone marrow aspirate and biopsy will only be performed to document CR
  • Laboratory Correlative Studies (optional) – to be performed on all patients at 3-4 hours after the first dose, at 3 months, and if patient consents to additional studies. Not all samples will be collected in all patients at all points
  • The laboratory correlative studies to be conducted may include Src kinase activity, Other molecular studies of response, ZAP70 kinase activity
  • EKG to be conducted every 3 months on return to clinic
  • Physical exam every 3 months.
Complete list of historical versions of study NCT00364286 on ClinicalTrials.gov Archive Site
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Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
Drug: Dasatinib (BMS-354825)
50mg Orally twice daily
Other Names:
  • Dasatinib
  • SPRYCEL ™
Experimental: Dasatinib
Dasatinib 50mg Orally twice daily.
Intervention: Drug: Dasatinib (BMS-354825)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2012
November 2012   (final data collection date for primary outcome measure)

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]).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00364286
2005-0497
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Principal Investigator: Susan O'Brien, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP