Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Marginal Zone Lymphoma

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Ibrutinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ibrutinib

Isaiah Dimery, MD

Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC).

Per Cheson:

CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.

The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.

Janssen Research & Development, LLC

Pharmacyclics LLC.

For "At Risk" we considered 60 because it was the efficacy population (with N=60) is used for OS

Subjects receive a daily dose of 560 mg of ibrutinib capsules

Participants were required to be of age 18 years or older

Age, Categorical

Sex: Female, Male

White

Black

Asian

Unknown

Race/Ethnicity, Customized

Isaiah Dimery, MD, Senior Medical Director

Single Arm, Intent to Treat Population

ORR (Overall Response Rate)

Patients receive daily dose of 560 mg of ibrutinib capsules.

DOR (Duration of Response)

Subjects receive daily dose of 560 mg of ibrutinib capsules.

Overall Study

Spots Global Cancer Trial Database for nmzl

Every month we try and update this database with for nmzl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nmzl

Every month we try and update this database with for nmzl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nmzl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.