A Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia

Stopped early · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

This is an open-label phase I/II study that will investigate the combination of dasatinib and rituximab therapy in patients with relapsed/refractory CLL. In phase I, eligible subjects will take either 100 mg or 140 mg of dasatinib daily along with rituximab on day 1 of each cycle for 6 cycles. In phase II, eligible subjects will all receive the same dose of dasatinib, as established in the phase I portion, along with rituximab on day 1 of each cycle for 6 cycles. The investigators hypothesize that the combination of dasatinib and rituximab will demonstrate efficacy in the treatment of patients with relapsed/refractory CLL.

Key facts

Study ID

NCT00949988

Run by

University of California, San Diego

People needed

3

Starts

2009-05-01

Expected to finish

2012-04-01

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed immunohistological diagnosis of B-cell CLL and Rai Stage III or IV disease, or stage 0-II disease that meets NCIWG criteria for active disease as indicated by any one of the following disease-related symptoms:
• Weight loss ≥ 10% within the previous 6 months
• Extreme fatigue
• Fever greater than 100.5 degrees Fahrenheit for ≥ 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure based on the development or worsening of anemia (< 10 g/dL) or thrombocytopenia (< 100,000 cells/mL)
• Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
• Massive (> 6 cm below the left costal margin) or progressive splenomegaly
• Bulky (>10 cm in cluster) or progressive lymphadenopathy
• Progressive lymphocytosis with > 50% increase over a 2-month period, or anticipated doubling time < 6 months
• Relapsed/ Refractory CLL that has progress with ≥1 prior treatment including a purine nucleoside analog-containing regimen, alkylating agent, or antibody (rituximab or alemtuzumab) or intolerance to purine nucleoside analog-containing therapy or unwilling to receive chemotherapy treatment.
• Age 18 or older
• ECOG Performance Status 0-2 (Appendix B)
• Adequate organ function:
• Serum creatinine < 2x the institutional upper limit of normal (ULN)
• Total bilirubin < 2x the institutional ULN
• AST, ALT < 2.5x the institutional ULN
• Serum sodium, potassium, magnesium, phosphate and calcium > the institutional lower limit of normal (LLN)
• Ability to take oral medication (dasatinib must be swallowed whole)
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (sensitivity ≤ 25 IU/L HCG) within 72 hrs prior to the start of study drug administration
• Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• No prior CLL-related treatment within 28 days before starting treatment with dasatinib.
• No concurrent use of other investigation agent.
• Concurrent medical condition which may increase the risk of toxicity, including:
• Uncontrolled or significant cardiovascular disease, including:
• Myocardial infarction, congestive heart failure or uncontrolled angina within 6 months
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
• Prolonged QTcF interval on pre-entry ECG (> 450 msec)
• 2nd/3rd degree heart block, uncontrolled hypertension or heart rate < 50
• History of significant bleeding disorder unrelated to CLL, including:
• Diagnosed congenital bleeding disorder (e.g., von Willebrand's disease)
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• Ongoing or recent significant GI bleeding within 3 months
• Hypokalemia or hypomagnesemia if it cannot be corrected
• Pleural or pericardial effusion of any grade
• Past or current malignancy, except for:
• Cervical carcinoma Stage 1B or less
• Non-invasive basal cell and squamous cell skin carcinoma
• Malignant melanoma with a complete response of a duration of > 10 years
• Other cancer diagnoses with a complete response of a duration of > 5 years
• Major systemic or other illness including active infection or active secondary malignancy that would, in the opinion of the Investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
• No history of allergic reaction to dasatinib.
• Use of Prohibited Concomitant Medications
• Subjects requiring any of the following prohibited therapies should not be enrolled:
• Bisphosphonates Intravenous bisphosphonates will be withheld for the first 8 weeks of treatment due to the risk of hypocalcemia. After the need for Ca2+ supplementation has been assessed and levels documented to be >LLN, subjects on prior bisphosphonate may be restarted with caution at the Investigator's discretion.

Where it is running

• University of California San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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