A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
apolizumab
+ laboratory biomarker analysis
+ pharmacological study
Chronic Disease+12
+ Hematologic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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 or IV small lymphocytic lymphoma treated with apolizumab. II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients. SECONDARY OBJECTIVES: I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed. III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy. IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo. OUTLINE: This is a multicenter study. 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. Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Ohio State University Medical Center
Columbus, United States