Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed · Phase 2

Conditions studied: Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Stage III Small Lymphocytic Lymphoma, Stage IV Small Lymphocytic Lymphoma

In brief

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 cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Key facts

Study ID

NCT00089154

Run by

National Cancer Institute (NCI)

People needed

32

Starts

2004-08-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Chronic Lymphocytic Leukemia Research Consortium (CRC) — La Jolla, California, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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