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

NCT01980628 | Completed Phase 2 Results

• 1 other identifier: PCYC-1121-CA
• Study Type: interventional
• Target: 63
• Locations: 5 countries
• Sites: 25

Brief Summary

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).

Conditions

Marginal Zone Lymphoma; B-cell Lymphoma

Keywords

MZL; NHL; SMZL; NMZL; MALT

Outcome Measures

Primary Outcomes (1)

• ORR (Overall Response Rate)

  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.

  Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.

Secondary Outcomes (1)

• DOR (Duration of Response)

  Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.

Study Arms (1)

ibrutinib

EXPERIMENTAL

ibrutinib capsules: 560 mg once daily

Drug: ibrutinib

Interventions

ibrutinib DRUG

Also known as: PCI-32765

ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen
• Men and women ≥18 years of age
• ECOG performance status of ≤2
• ≥1 measurable lesion site on CT scan (\>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead. (Subjects with spleen-only disease are considered as not having measurable disease.)
• Life expectancy of \>3 months, in the opinion of the investigator

You may not qualify if:

• Medically apparent CNS lymphoma or leptomeningeal disease
• History of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years
• History of allogeneic stem-cell (or other organ) transplantation
• Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug
• Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug
• Concurrent use of warfarin or other vitamin K antagonists
• Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication.
• Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug
• Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia
• Inadequate organ function as defined on laboratory tests

Sponsors & Collaborators

• Pharmacyclics LLC.: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (25)

Site Reference ID/Investigator# 837

Tucson, Arizona, 85719, United States

Location

Site Reference ID/Investigator# 047

Duarte, California, 91010, United States

Location

Site Reference ID/Investigator# 377

Santa Monica, California, 90095, United States

Location

Site Reference ID/Investigator# 763

West Palm Beach, Florida, 33401, United States

Location

Site Reference ID/Investigator# 033

Atlanta, Georgia, 30322, United States

Location

Site Reference ID/Investigator# 370

Chicago, Illinois, 60611, United States

Location

Site Reference ID/Investigator# 195

Detroit, Michigan, 48202, United States

Location

Site Reference ID/Investigator# 350

New Hyde Park, New York, 11042, United States

Location

Site Reference ID/Investigator# 745

New York, New York, 08724, United States

Location

Site Reference ID/Investigator # 200

New York, New York, 10065, United States

Location

Site Reference ID/Investigator # 407

New York, New York, 10065, United States

Location

Site Reference ID/Investigator# 220

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 348

Seattle, Washington, 98109, United States

Location

Site Reference ID/Investigator# 560

Ghent, Oost-vlaanderen, Belgium

Location

Site Reference ID/Investigator# 142

Pierre-Bénite, Auvergne-Rhône-Alpes, France

Location

Site Reference ID/Investigator# 737

Rouen, Haute-normandie, France

Location

Site Reference ID/Investigator# 750

Lille, Hauts-de-France, France

Location

Site Reference ID/Investigator# 749

La Roche-sur-Yon, Pays de la Loire Region, France

Location

Site Reference ID/Investigator# 736

Nantes, Pays de la Loire Region, France

Location

Site Reference ID/Investigator# 742

Rennes, France

Location

Site Reference ID/Investigator# 735

Paris, Île-de-France Region, France

Location

Site Reference ID/Investigator# 669

Mainz, Rhineland-Palatinate, Germany

Location

Site Reference ID/Investigator# 030

Manchester, England, United Kingdom

Location

Site Reference ID/Investigator# 814

Oxford, England, United Kingdom

Location

Site Reference ID/Investigator# 368

Plymouth, England, United Kingdom

Location

Related Publications (2)

• Noy A, de Vos S, Coleman M, Martin P, Flowers CR, Thieblemont C, Morschhauser F, Collins GP, Ma S, Peles S, Smith SD, Barrientos JC, Chong E, Wu S, Cheung LW, Kwei K, Hauns B, Arango-Hisijara I, Chen R. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. Blood Adv. 2020 Nov 24;4(22):5773-5784. doi: 10.1182/bloodadvances.2020003121.

  PMID: 33227125 DERIVED

• Noy A, de Vos S, Thieblemont C, Martin P, Flowers CR, Morschhauser F, Collins GP, Ma S, Coleman M, Peles S, Smith S, Barrientos JC, Smith A, Munneke B, Dimery I, Beaupre DM, Chen R. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017 Apr 20;129(16):2224-2232. doi: 10.1182/blood-2016-10-747345. Epub 2017 Feb 6.

  PMID: 28167659 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Lymphoma, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Isaiah Dimery, MD, Senior Medical Director
• Organization: Pharmacyclics, LLC

idimery@pcyc.com

408-215-3579

Study Officials

• Isaiah Dimery, MD

  Pharmacyclics LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 11, 2013
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: October 2, 2017
• Last Updated: October 16, 2019
• Results First Posted: February 10, 2017

Record last verified: 2019-10

Locations

US (13); DE (1); GB (3); BE (1); FR (7)