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

2014-08-27 03:54:10 | BioPortfolio

Summary

RATIONALE: Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Description

OBJECTIVES:

Primary

- 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.

- Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients.

Secondary

- Correlate clinical response with genetic subtype of leukemia or lymphoma in patients treated with this drug.

- Correlate pharmacokinetic clearance of this drug with 1D10 antigen density on leukemic or lymphoma cells and with response to and toxic effects associated with this drug in these patients.

- Correlate clinical response with reactive oxygen species and specific signaling pathways' promotion of drug-mediated apoptosis in patients treated with this drug.

- Determine the cellular properties that convey resistance to this drug in CLL in vivo in these patients.

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.

PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study within 8.5-32 months.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

apolizumab

Location

Rebecca and John Moores UCSD Cancer Center
La Jolla
California
United States
92093-0663

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:10-0400

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Medical and Biotech [MESH] Definitions

A replication-defective strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) capable of transforming lymphoid cells and producing a rapidly progressing lymphoid leukemia after superinfection with FRIEND MURINE LEUKEMIA VIRUS; MOLONEY MURINE LEUKEMIA VIRUS; or RAUSCHER VIRUS.

A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) producing leukemia of the reticulum-cell type with massive infiltration of liver, spleen, and bone marrow. It infects DBA/2 and Swiss mice.

A strain of Murine leukemia virus (LEUKEMIA VIRUS, MURINE) arising during the propagation of S37 mouse sarcoma, and causing lymphoid leukemia in mice. It also infects rats and newborn hamsters. It is apparently transmitted to embryos in utero and to newborns through mother's milk.

A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

A lymphoid leukemia characterized by a profound LYMPHOCYTOSIS with or without LYMPHADENOPATHY, hepatosplenomegaly, frequently rapid progression, and short survival. It was formerly called T-cell chronic lymphocytic leukemia.

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