Status:
COMPLETED
Alemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia in Partial Remission or Complete Remission
Lead Sponsor:
Leeds Cancer Centre at St. James's University Hospital
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them...
Detailed Description
OBJECTIVES: Primary * Determine the rate of achieving minimum residual disease (MRD) negativity after treatment with alemtuzumab in patients with B-cell chronic lymphocytic leukemia (B-CLL) who have...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) meeting the following criterion:
- Confirmed by characteristic immunophenotype on peripheral blood flow cytometry
- In complete or partial remission after prior therapy for B-CLL
- No treatment failure after receiving prior alemtuzumab therapy
- Minimal residual disease (MRD) status meeting 1 of the following criteria:
- Detectable B-CLL MRD (i.e., MRD-positive) as shown by peripheral blood or bone marrow involvement
- Undetectable B-CLL MRD (i.e., MRD-negative remission)
- Lymph nodes \< 2 cm in maximum diameter
- No persisting severe pancytopenia due to prior therapy rather than disease, as defined by the following criteria:
- Neutrophil count \< 5,000/mm\^3
- Platelet count \< 50,000/mm\^3
- No clinically progressive disease (i.e., peripheral blood B-cell count ≥ 5,000/mm³)
- No mantle cell lymphoma
- No CNS involvement with B-CLL
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- Creatinine \< 2 times upper limit of normal (ULN)\*
- Bilirubin \< 2 times ULN\*
- No known HIV positivity
- No concurrent active infection
- No history of anaphylaxis after exposure to rat or mouse-derived, complementary-determining region-grafted humanized monoclonal antibodies
- No other concurrent severe diseases or mental disorders
- No concurrent active secondary malignancy NOTE: \*Unless secondary to direct infiltration of the liver by B-CLL or hemolysis
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
- Any other prior therapy allowed
- At least 6 months since completion of last therapy for B-CLL
- More than 6 weeks since prior investigational agents
- No other concurrent cytotoxic agents
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00458523
Start Date
December 1 2006
End Date
February 1 2008
Last Update
August 12 2013
Active Locations (2)
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1
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
2
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX