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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
PrECOG, LLC.
Study ID
NCT03323151
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Mantle-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixazomib — DRUG
    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.
  • Ixazomib — DRUG
    Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
  • Ibrutinib — DRUG
    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.
  • Ibrutinib — DRUG
    Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.

Study Details

Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib. Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy. Ixazomib is in a class of medications called proteasome inhibitors. Cancer cells depend on proteasome to provide this protein metabolism (turnover) function to regulate their growth and survival. Ixazomib disrupts a cancer cells' ability to survive by blocking the proteasome and disrupting protein metabolism. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see whether the addition of ixazomib to ibrutinib chemotherapy is effective in treating people who have relapsed or refractory MCL and to examine the side effects associated with ixazomib in combination with ibrutinib.

Key Dates

Start date
Aug 13, 2018
Status verified
Jan 2024
Primary completion
Sep 22, 2022
Completion
Sep 7, 2023

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Ixazomib & Ibrutinib
    Ixazomib and Ibrutinib will be given by mouth until progression or unacceptable toxicity.
  • Experimental: Phase II: Ixazomib & BTK-Naive
    Patients who are BTK-Naive will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.
  • Experimental: Phase II: Ixazomib & BTK Pre-Treated (Closed 8/7/2020)
    Patients previously treated with a BTK will receive Ixazomib and Ibrutinib by mouth until progression or unacceptable toxicity.

Primary Outcome Measure

Phase I: Dose Limiting Toxicities (DLT) Rate [ Time Frame: 1 month ]

Locations (14)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
Carle Cancer CenterUrbanaIllinois61801-
University of KansasOverland ParkKansas66210-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Laura and Isaac Perlmutter Cancer Center at NYUNew YorkNew York10016-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of VirginiaCharlottesvilleVirginia22908-
West Virginia UniversityMorgantownWest Virginia26506-
Gundersen Health SystemLa CrosseWisconsin54601-
University of WisconsinMadisonWisconsin53792-
Medical College of WisconsinMilwaukeeWisconsin53226-
ProHealth CareWaukeshaWisconsin53188-

Find similar trials in Atlanta, GA

By research site
Winship Cancer Institute of Emory University· Atlanta, GAGeorgia Cancer Center at Augusta University· Augusta, GACarle Cancer Center· Urbana, ILUniversity of Kansas· Overland Park, KSWashington University School of Medicine· St Louis, MORutgers Cancer Institute of New Jersey· New Brunswick, NJ

Related Studies