LeukemiaPhase 2NCT00364286
Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
A Phase 2 study testing Dasatinib (BMS-354825) in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Dasatinib (BMS-354825)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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]).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Dasatinib (BMS-354825)
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Leukemia, Lymphoma, Dasatinib, BMS-354825
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib (BMS-354825)Drug
Also called Dasatinib, SPRYCEL ™
50mg Orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Experimental | Dasatinib 50mg Orally twice daily. Receives: Drug: Dasatinib (BMS-354825) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Susan O'Brien, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364286
- Sponsor's protocol ID
- 2005-0497
- Other IDs
- NCI-2012-01562
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2006
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
- ClinicalTrials.gov ID
- NCT00364286
- Acronym / sponsor ID
- 2005-0497
- Keywords
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic Leukemia, Leukemia, Lymphoma, Dasatinib, BMS-354825
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Aug 2006
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 21 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Experimental | Drug: Dasatinib (BMS-354825)Dasatinib 50mg Orally twice daily. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib (BMS-354825)Also: Dasatinib, SPRYCEL ™50mg Orally twice daily | Drug | Dasatinib |
Primary outcome
Participants With Objective Response
Time frame: up to 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT M.D. Anderson's WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan O'Brien, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib (BMS-354825) in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Objective Response (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.