Can a targeted drug tame CLL? small trial seeks answers
NCT ID NCT00364286
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested the drug dasatinib in 17 people with chronic lymphocytic leukemia (CLL) who had already received other treatments. The goal was to see if dasatinib could shrink or control the cancer. Participants took the drug by mouth twice daily, and doctors checked for responses every three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dasatinib (a targeted cancer drug taken orally)
- What this could lead to
- If it works, this could offer a new treatment option to help control CLL in patients who have already tried other therapies.
- What could go wrong
- This is a small, early-phase trial with only 17 participants, so results may not apply to everyone. The drug may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
17 people
The number who actually took part.
- Start date
-
Aug 2006
- Finished
-
Nov 2012
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[e.g., danaparoid, dalteparin, tinzaparin, enoxaparin\]).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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