Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for Noncontiguous Stage II Small Lymphocytic Lymphoma
Eligibility Criteria
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
Sites / Locations
- Chronic Lymphocytic Leukemia Research Consortium (CRC)
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (apolizumab)
Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.