Chronic Lymphocytic Leukemia Clinical Trial
Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory leukemia-cll/" >chronic lymphocytic leukemia or small lymphocytic lymphoma.
Full Description
OBJECTIVES:
Determine a recommended phase II dose of IDEC-152 monoclonal antibody in patients with relapsed or recurrent chronic lymphocytic leukemia.
Determine the safety profile of this drug in these patients.
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
Determine the efficacy of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive IDEC-152 monoclonal antibody IV over at least 2 hours on days 1, 2, 8, 15, and 22.
Cohorts of 3-10 patients receive escalating doses of IDEC-152 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3, 2 of 6, or 3 of 10 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 15-50 patients will be accrued for this study within 6 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma
Stage III-IV OR
Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics:
Rapid doubling of peripheral lymphocyte count
Progressive lymphadenopathy
Progressive splenomegaly
B symptoms
Grade 2 or 3 fatigue
CD23+ disease
Progressive disease after at least 1 prior chemotherapy course
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
WHO 0-2
Life expectancy
At least 6 months
Hematopoietic
Platelet count at least 50,000/mm^3
Hepatic
Bilirubin no greater than 2.0 mg/dL
AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Renal
Creatinine no greater than 1.5 times ULN
Cardiovascular
No New York Heart Association class III or IV cardiac disease
No myocardial infarction within the past 6 months
No unstable arrhythmia
No evidence of ischemia on EKG within the past 14 days
Pulmonary
FEV_1 at least 60% of predicted
DLCO at least 55% of predicted
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study treatment
HIV negative
No secondary malignancy requiring active treatment (except hormonal therapy)
No serious nonmalignant disease that would preclude study participation
No active uncontrolled bacterial, viral, or fungal infection
No clinically active autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
More than 4 weeks since prior anticancer biologic therapy
More than 4 weeks since prior anticancer radioimmunotherapy
No prior exposure to IDEC-152 or anti-CD23 antibodies
Chemotherapy
See Disease Characteristics
More than 4 weeks since prior anticancer chemotherapy
Endocrine therapy
Concurrent hormonal therapy allowed for second malignancy
Radiotherapy
More than 4 weeks since prior anticancer radiotherapy
Surgery
More than 4 weeks since prior major surgery (except for diagnostic surgery)
Other
More than 4 weeks since prior anticancer investigational therapy
No other concurrent anticancer therapy
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There is 1 Location for this study
New York New York, 10021, United States
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