Status:
TERMINATED
Dasatinib With Fludarabine and Rituximab in Relapsed and Refractory CLL and SLL
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are similar diseases of the white blood cells and are typically treated the same way. Recent research shows that a key enzyme in...
Detailed Description
* Since the purpose of the study is to determine the response rate of the 3 drug regimen, everyone who participates will receive the same dose of the study drug, dasatinib and the 2 standard drugs, fl...
Eligibility Criteria
Inclusion
- CLL/SLL with cells positive by flow cytometry (or immunostaining) for CD19, CD23, and CD5. Patients may be CD23 negative as long as they are also cyclin D1 negative or t(11;14) negative.
- Participants must have received at least 1 prior regimen containing a purine analogue or have received at least 2 chemotherapy regimens not containing a purine analogue. Patients may be refractory to single-agent purine analogue treatment, but patients may not be refractory to a combination of purine analogue with rituximab. Patients may have received rituximab.
- 18 years of age or older
- Able to take oral medications
- ECOG Performance Status of 2 or better
- Adequate organ function to tolerate chemotherapy
- Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration and agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study is stopped.
- Require treatment based on 1996 NCI-WG criteria updated in 2008 by the IWCLL
- Patient agrees to discontinue St. John's Wort while receiving dasatinib therapy and stop at least 5 days before starting dasatinib.
- Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib
Exclusion
- Pregnant or breastfeeding women
- Uncontrolled angina, congestive heart failure, or MI within 6 months
- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias
- Prolonged QTc interval on pre-entry ECG
- Uncontrolled hypertension
- Hypokalemia or hypomagnesemia that is not corrected prior to dasatinib administration
- Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes
- Known HIV positive
- Known significant bleeding disorder unrelated to CLL
- Any significant pleural or pericardial effusion
- Patients may not have another malignancy that is uncontrolled or requires treatment within a year of starting this study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01173679
Start Date
July 1 2010
End Date
January 1 2015
Last Update
April 14 2017
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115