Status:
COMPLETED
Lower But More Frequent Dose Rituximab to Treat Chronic Lymphocytic Leukemia
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
21-99 years
Phase:
PHASE1
Brief Summary
This study will test the safety and effectiveness of using lower-dose rituximab given more frequently for treating chronic lymphocytic leukemia (CLL). Studies have shown that, used once a week for 4 w...
Detailed Description
Rituximab is FDA approved for the treatment of relapsed or refractory low grade or follicular CD20+ B cell non Hodgkin's lymphoma (375 mg/m(2) IV infusion once weekly for 4 or 8 doses). Recently, ritu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients diagnosed with Chronic Lymphocytic Leukemia
- Prior therapy with fludarabine or a fludarabine containing regimen
- CD20 expression on CLL cells
- Neutrophil count ANC greater than 500/mm(3)
- Platelet count greater than 30K/mm(3)
- Age 21-99
- EXCLUSION CRITERIA
- Bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in largest diameter
- Evidence for transformation into high grade lymphoma (Richter's transformation)
- ECOG performance 3 or higher
- Other concurrent anticancer therapies
- Less than 3 months from last systemic therapy for CLL
- Less than 6 months from last monoclonal antibody therapy
- More than 10 doses rituximab, within 12 months preceeding protocol enrollment, either as single agent or in a combination chemotherapy regimen
- Chronic or current clinically significant infection, including HIV positivity or hepatitis C
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy
- History of mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis)
- Known anaphylaxis or IgE mediated hypersensitivity to murine proteins or to any component of this product
- Inability to self inject the study medication or to have it administered by a third person
- Inability to understand the investigational nature of the study ability to provide informed consent
Exclusion
Key Trial Info
Start Date :
August 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00366418
Start Date
August 10 2006
End Date
June 11 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892