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Clinical Trial Detail

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

Complete title: A Response-Adapted Clinical Trial of Weekly Carfilzomib with or without Rituximab for Waldenstrom's Macroglobulinemia and Marginal Zone Lymphoma

Research Study Number 9702
 
Principal Investigator Stephen Smith
 
Phase II

Research Study Description

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. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number 9702
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Hematologic Malignancies; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Immunoproliferative Disorders; Waldenstrom Macroglobulinemia; Cardiovascular Diseases; Lymphoma, B-Cell; Neoplasms, Plasma Cell; Paraproteinemias; Immune System Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Lymphoma, B-Cell, Marginal Zone; Vascular Diseases

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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