Primary Outcome Measures:
- Maximum tolerated dose (MTD) and toxicity of apolizumab [ Designated as safety issue: Yes ]
- Antitumor activity at the MTD at the end of study treatment [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effects of treatment in patients with chronic lymphocytic leukemia (CLL) as measured by microarray profiling pre-treatment and at the end of study treatment [ Designated as safety issue: No ]
- Effects of treatment in patients with CLL on kinetics of apoptosis as measured by fluorescent-activated cell sorting (FACS) analysis of Annnexin 5 pre-treatment and at the end of study treatment [ Designated as safety issue: No ]
- Effects of treatment on T-cell and B-cell levels pre-treatment, during treatment, and at the end of study treatment [ Designated as safety issue: No ]
OBJECTIVES:
- Determine the maximum tolerated dose of apolizumab when administered with rituximab in patients with relapsed CD20 and 1D10-positive B-cell lymphoma, Waldenstrom's macroglobulinemia, or chronic lymphocytic leukemia.
- Determine the toxicity of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of apolizumab.
Patients receive apolizumab IV over several hours on day 1 followed 24-36 hours later by rituximab IV. Treatment repeats every 7 days for 4 weeks. At 12 weeks after completion of treatment, patients with stable disease or a complete or partial response may receive additional treatment for up to 3 courses.
Cohorts of 2-6 patients receive escalating doses of apolizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 24 additional patients (12 with chronic lymphocytic leukemia or Waldenstrom's macroglobulinemia and 12 with lymphoma) are treated at the MTD.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-69 patients will be accrued for this study within 12 months.