TerminatedPhase 2

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

Stopped: Terminated due to low accrual.

United States4 participantsStarted 2017-12-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 thera…

What they're measuring

Overall Response Rate

Timeframe: Up to 1 year

Trial details

NCT IDNCT03269552

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-28

Results submitted2019-12-02