Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Completed · Phase 1

Conditions studied: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hematopoietic/Lymphoid Cancer, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

In brief

This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine with or without rituximab in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with fludarabine with or without rituximab may kill more cancer cells.

Key facts

Study ID

NCT00068315

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2003-07-01

Last updated by the study team

2013-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes:
• Follicular lymphoma:
• Grade I follicular small cleaved cell;
• Grade II follicular mixed cell;
• Grade II follicular large cell;
• Diffuse small cleaved cell;
• Small lymphocytic lymphoma;
• Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)
• AND
• Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue [MALT] lymphoma);
• Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma);
• Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes);
• Mantle cell lymphoma:
• No blastic phase mantle cell lymphoma
• Relapsed or refractory, progressive disease:
• First, second, or third relapse
• Measurable disease, meeting 1 of the following criteria:
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan (for NHL patients);
• OR:
• Lymphocytosis > 50,000/mm3 OR evidence of progressive bone marrow infiltration failure (e.g., hemoglobin 10 g/dL) OR thrombocytopenia (i.e., platelet count < 100,000/mm3) with > 30% infiltration of bone marrow by leukemia (for CLL patients)
• No measurable lymphadenopathy (for CLL and Waldenstrom's macroglobulinemia patients)
• No evidence of CNS lymphoma
• Performance status:
• ECOG 0-2
• Life expectancy:

Where it is running

• Mercy Medical Center — Canton, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Southwest General Health Center Ireland Cancer Center — Middleburg Heights, Ohio, United States
• UHHS-Chagrin Highlands Medical Center — Orange, Ohio, United States
• University Suburban Medical Center — South Euclid, Ohio, United States
• UHHS-Westlake Medical Center — Westlake, Ohio, United States

Full record on ClinicalTrials.gov

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