Overview

Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma

Status:
Terminated
Trial end date:
2018-12-28
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial studies how well carfilzomib with or without rituximab work in treating patients with Waldenstrom macroglobulinemia or marginal zone lymphoma that is previously untreated, has come back, or does not respond to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving carfilzomib alone when disease is responding or with rituximab when disease is not responding may work better in treating patients with Waldenstrom macroglobulinemia or marginal zone lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunoglobulins
Rituximab
Criteria
Inclusion Criteria:

- Waldenstrom's macroglobulinemia (WM) or marginal zone lymphoma (MZL) based on
institutional pathology review; patients may have either previously untreated or
relapsed/refractory disease

- Measurable disease: for WM presence of monoclonal IgM immunoglobulin concentration on
serum electrophoresis, with lymphoplasmacytic marrow infiltrate; for MZL: measurable
nodal disease measuring at least 1.5 cm in longest dimension, or splenomegaly

- Indication for initiation of therapy

- Absolute neutrophil count (ANC) > 1,000/uL unless disease-related (due to marrow
infiltration or splenomegaly)

- Platelet count > 75,000/uL unless disease-related (due to marrow infiltration or
splenomegaly)

- Serum creatinine < 2.5 mg/dL or creatinine clearance > 30 cc/min

- Bilirubin < 2 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN

- All patients must be informed of the investigational nature of this study and have
given written consent in accordance with institutional and federal guidelines

- Expected survival of > 90 days

- Females of childbearing potential (FCBP) must agree to pregnancy testing and to
practice contraception

- Male subjects must agree to practice contraception

Exclusion Criteria:

- Known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B positivity
(subjects with hepatitis B surface antigen [SAg] or core antibody positivity, who are
receiving and responding to antiviral therapy directed at hepatitis B or are negative
for hepatitis B virus [HBV] deoxyribonucleic acid [DNA], are allowed)

- Candidate for potentially curative antibiotic therapy for gastric mucosa-associated
lymphoid tissue (MALT); (gastric MALT lymphoma patients with stage I/II helicobacter
[H.] pylori positive lymphoma must fail therapy with H.-pylori directed therapy before
being considered for this study)

- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher

- Known active central nervous system (CNS) involvement

- Pregnant or lactating females

- Inadequate cardiac function, as measured by left ventricular ejection fraction (LVEF)
that is less than or equal to 40%, or the presence of New York Heart Association
(NYHA) classification of greater than stage II congestive heart failure

- Significant neuropathy (grades 3-4, or grade 2 with pain) within 14 days prior to
screening

- Uncontrolled inter-current illness including, but not limited to, unstable angina,
recent myocardial infarction within 6 months of screening and uncontrolled cardiac
arrhythmias, psychiatric illness, or psychosocial difficulty that would limit
compliance with study requirements

- Non-hematologic malignancy within the past 3 years with the exception of a) adequately
treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b)
carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason grade 6 or
less with stable prostate-specific antigen levels; or d) cancer considered cured by
surgical resection or unlikely to impact survival during the duration of the study