A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

September 22, 2022

Study Completion Date

September 7, 2023

Conditions
Mantle-Cell Lymphoma
Interventions
DRUG

Ixazomib

Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities. Note: Ixazomib dose will not be de-escalated but remain at 3 mg.

DRUG

Ixazomib

Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.

DRUG

Ibrutinib

Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.

DRUG

Ibrutinib

Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.

Trial Locations (14)

10016

Laura and Isaac Perlmutter Cancer Center at NYU, New York

19104

University of Pennsylvania Abramson Cancer Center, Philadelphia

22908

University of Virginia, Charlottesville

26506

West Virginia University, Morgantown

30322

Winship Cancer Institute of Emory University, Atlanta

30912

Georgia Cancer Center at Augusta University, Augusta

53188

ProHealth Care, Waukesha

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin, Madison

54601

Gundersen Health System, La Crosse

61801

Carle Cancer Center, Urbana

63110

Washington University School of Medicine, St Louis

66210

University of Kansas, Overland Park

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

lead

PrECOG, LLC.

OTHER