Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Completed · Phase 1/Phase 2

Conditions studied: Relapsed Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma

In brief

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.

Key facts

Study ID

NCT02077166

Run by

Pharmacyclics LLC.

People needed

138

Starts

2014-03-13

Expected to finish

2020-12-17

Last updated by the study team

2022-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed relapsed/ refractory DLBCL
• Must have previously received first line treatment regimen
• Must be ineligible for high dose therapy/ stem cell transplantation
• Measurable disease sites on computed tomography (CT) scan (>1.5 cm in longest dimension)
• prothrombin time/international normalized ratio (PT/INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time [aPTT]) <1.5 x ULN
• Men and women ≥18 years of age
• Eastern Cooperative Oncology Group (ECOG) < 2
• Adequate hepatic and renal function
• Adequate hematologic function

You may not qualify if…

• Medically apparent central nervous system lymphoma or leptomeningeal disease
• History of allogeneic stem-cell (or other organ) transplantation
• Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
• Radio- or toxin-immunoconjugates within 10 weeks
• Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cedar Sinai Medical Center — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of Florida — Gainesville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Summit Medical Group — Morristown, New Jersey, United States
• Weill Cornell Medical Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University of Cincinnati Health Barrett Center — Cincinnati, Ohio, United States
• Mid-Ohio Oncology/ Hematology — Columbus, Ohio, United States
• University of TN Medical Center — Knoxville, Tennessee, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• Baylor Charles Sammons Cancer Center — Dallas, Texas, United States
• The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Medical Oncology Associates, PS — Spokane, Washington, United States
• Northwest Medical Specialities, PLLC — Tacoma, Washington, United States
• Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg — Antwerp, Belgium
• CHU Brugmann — Brussels, Belgium
• Cliniques Universitaires Saint-Luc — Brussels, Belgium

Full record on ClinicalTrials.gov

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