Status:
COMPLETED
Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Noncontiguous Stage II Small Lymphocytic Lymphoma
Recurrent Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate canc...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed hematologic malignancy of 1 of the following histologies:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Noncontiguous stage II or stage III or IV disease
- Received \>= 1 form of prior immunotherapy or chemotherapy
- Completed therapy at least 4 weeks ago
- Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
- Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of \>= 2 weeks)
- Progressively worsening anemia or thrombocytopenia
- Progressively worsening lymphadenopathy
- Massive splenomegaly or hypersplenism
- Hyperlymphocytosis (WBC \> 200,000/mm\^3) OR lymphocyte doubling time \< 12 months
- Marrow failure due to marrow infiltration by leukemia or lymphoma
- Leukemia cells must express 1D10 antigen \> 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
- Performance status - ECOG 0-2
- At least 2 years
- Platelet count \>= 50,000/mm\^3 (transfusion independent)
- Bilirubin =\< 3 mg/dL (unless due to tumor involvement)
- Creatinine =\< 2.0 mg/dL
- No decompensated congestive heart failure
- No unstable angina
- No myocardial infarction within the past 6 months not corrected by surgery or percutaneous transluminal coronary angioplasty
- No active infection requiring oral or IV antibiotics
- No other malignancy that limits life expectancy to \< 2 years or that requires active anticancer therapy within 4 weeks of study entry
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study treatment
- Recovered from prior immunotherapy
- More than 3 months since prior alemtuzumab or rituximab
- No prior apolizumab
- Recovered from prior chemotherapy
- More than 4 weeks since prior anticancer hormonal therapy
- More than 4 weeks since prior anticancer radiotherapy
- More than 4 weeks since prior anticancer surgery
- At least 4 weeks since other prior therapy for CLL or SLL and recovered
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00089154
Start Date
August 1 2004
Last Update
July 16 2013
Active Locations (2)
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1
Chronic Lymphocytic Leukemia Research Consortium (CRC)
La Jolla, California, United States, 92093-0820
2
Ohio State University Medical Center
Columbus, Ohio, United States, 43210