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| ID | Type | Description | Link |
|---|---|---|---|
| OSU 0410 | |||
| CLLRC-OSU-0410 | |||
| CDR0000378072 | |||
| OSU-0410 | |||
| NCI-6257 | |||
| R21CA091564 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (apolizumab) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apolizumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (CR+PR) | Up to 3 years | |
| Progression-free survival rate | Up to 3 years | |
| Frequency and severity of treatment-related adverse events | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic clearance | Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months |
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Inclusion Criteria:
Histologically confirmed hematologic malignancy of 1 of the following histologies:
Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
Received >= 1 form of prior immunotherapy or chemotherapy
Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| John Byrd | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic Lymphocytic Leukemia Research Consortium (CRC) | La Jolla | California | 92093-0820 | United States | ||
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| laboratory biomarker analysis | Other | Correlative studies |
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| pharmacological study | Other | Correlative studies |
|
|
| Ohio State University Medical Center |
| Columbus |
| Ohio |
| 43210 |
| United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C448699 | apolizumab |
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