Status:
COMPLETED
A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Bayer
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and ...
Detailed Description
OBJECTIVES: * To determine the response rate in patients with previously untreated B-cell chronic lymphocytic leukemia treated with alemtuzumab and rituximab. * To evaluate the toxicity of alemtuzuma...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL)\*, as defined by the following criteria:
- Peripheral blood absolute lymphocyte count \> 5,000/mm³
- Small- to moderate-size lymphocytes with \< 55% prolymphocytes, atypical lymphocytes, or lymphoblasts
- Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:
- Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)
- B-cell expresses either lambda or kappa light chains
- Surface immunoglobulin with low-cell surface density expression NOTE: \*Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
- Requires therapy, as indicated by ≥ 1 of the following criteria:
- Unintentional weight loss \> 10% within the past 6 months
- Extreme fatigue (i.e., ECOG performance status 2)
- Fevers \> 100.5°F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin \< 10 g/dL) and/or thrombocytopenia (platelet count \< 100,000/mm³)
- Massive (i.e., \> 6 cm below left costal margin) or progressive splenomegaly
- Massive nodes/clusters (\> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage
- Progressive lymphocytosis with an increase of \> 50% over 2 months or an anticipated doubling time \< 6 months
- Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,000/mm³\*
- Platelet count ≥ 50,000/mm³\*
- Hemoglobin ≥ 10 g/dL\*
- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance \> 40 mL/min
- Bilirubin \< 2 mg/dL
- AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No active autoimmune anemia or thrombocytopenia
- No active infection requiring oral or intravenous antibiotics
- No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: \*If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.
- PRIOR CONCURRENT THERAPY:
- Prior corticosteroid therapy allowed
- No prior cytotoxic therapy (other than corticosteroids)
Exclusion
Key Trial Info
Start Date :
September 26 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00858117
Start Date
September 26 2005
End Date
January 24 2013
Last Update
November 6 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611