Spots Global Cancer Trial Database for Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma
Official Title: A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)
Study ID: NCT02568553
Conditions
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with blinatumomab in the proposed regimen. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity anti-tumor response (complete response \[CR\] and partial response \[PR\] as per International workshop lymphoma response criteria). II. To investigate the immune response to blinatumomab alone and in combination with lenalidomide. III. To document the infection rate with a 96-hour bag change schedule for blinatumomab. OUTLINE: This is a dose-escalation study of lenalidomide. INDUCTION: Patients receive blinatumomab intravenously (IV) continuously on days 1-56 and lenalidomide orally (PO) on days 29-49 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving response including stable disease receive blinatumomab IV continuously on days 1-7 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receiving response including stable disease after completion of Consolidation receive lenalidomide PO on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Keck Medical Center of USC Pasadena, Pasadena, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Contact Details
Name: Joseph M Tuscano
Affiliation: City of Hope Comprehensive Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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