Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Lymphoma

Recurrence

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Marginal Zone Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Bortezomib

Cladribine

Antineoplastic Agents, Immunological

Immunologic Factors

Immunosuppressive Agents

* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles

375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.

rituximab

1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.

bortezomib

4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.

cladribine

Daniel O. Persky, MD

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 cladribine and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine and rituximab works in treating patients with advanced mantle cell lymphoma or indolent lymphoma.

OBJECTIVES:

Primary

* Determine the 2-year progression-free survival of patients with advanced mantle cell lymphoma or indolent lymphoma treated with bortezomib, cladribine, and rituximab.

Secondary

* Determine the 2-year overall survival of patients treated with this regimen.
* Determine the complete response and overall response rate in patients treated with this regimen.
* Describe the long- and short-term toxicity of this regimen in these patients.
* Determine the prognostic importance of Aurora kinase A in patients treated with this regimen.
* Determine the cytokine profiles for each lymphoma subtype and how they change with this regimen.
* Evaluate the prognostic importance of major carcinogenic pathways using tissue microarray.

OUTLINE: Patients receive bortezomib IV on days 1 and 4, cladribine IV over 2 hours on days 1-5, and rituximab IV on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and after course 1 for cytokine profile studies. Previously collected tissue samples are obtained for analysis of Aurora kinase A and B, Ki-67, cyclin D, Bcl-2, phosphor-HisH3, c-Met, and VEGF expression by using tissue microarray (IHC staining), reverse transcriptase-PCR, and/or western blotting.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma

A Phase II, Open-Label Study of Bortezomib (Velcade), Cladribine and Rituximab (VCR) in Advanced, Newly Diagnosed and Relapsed/Refractory Mantle Cell and Indolent Lymphomas

PFS was calculated from the first dose of study drug to the first documentation of disease progression, death regardless of cause, or change in therapy due to disease progression, whichever occurred first. If disease progression did not occur by the end of treatment, patients were evaluated every 3 months until progression with physical examination, laboratory studies, and conventional computed tomographic imaging, up to a maximum of 2 years. The Kaplan-Meier product-limit method will be used to estimate progression-free survival in the presence of censoring.

National Cancer Institute (NCI)

University of Arizona

* Rituximab 375 mg/m2 IV day1
* Cladribine 4 mg/m2 IV over 2 hours days 1-5
* Bortezomib 1.3 mg/m2 IV days 1 and 4
* Repeat every 28 days for a maximum of 6 cycles

rituximab: 375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.

bortezomib: 1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.

cladribine: 4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma	NCT00980395	Lymphoma Mantle Cell Lym... Indolent Lympho... SLL	rituximab bortezomib cladribine	18 Years -	University of Arizona
Bortezomib, Cladribine, and Rituximab in Treating Patients With Advanced Mantle Cell Lymphoma or Indolent Lymphoma	NCT00980395	Lymphoma Mantle Cell Lym... Indolent Lympho... SLL	rituximab bortezomib cladribine	18 Years -	University of Arizona

Spots Global Cancer Trial Database for extranodal marginal zone bcl mucosa assoc lymphoid tissue