Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT03093831 | Terminated Phase 2

• 1 other identifier: 54179060LYM2009
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the efficacy and safety of Ibrutinib in predominantly Asian patients with relapsed or refractory marginal zone lymphoma.

Conditions

Lymphoma, B-Cell, Marginal Zone

Outcome Measures

Primary Outcomes (1)

• Overall Response Rates

  Proportion of patients who achieve either a Complete Response (CR) or Partial Response (PR) as best response

  From time of first study drug administration until best overall response of CR or PR is achieved, up to 3 years

Secondary Outcomes (4)

• Progression-Free Survival

  From time of first study drug administration until first occurence of disease progression or death from any cause, up to 3 years

• Overall Survival

  From time of first study drug administration until death from any cause, up to 3 years

• Frequency and severity of adverse events

  From the time the ICF is signed until 30 days after the last dose of the study drug

• Frequency of adverse events requiring discontinuation of study drug or dose reductions

  From the time the ICF is signed until 30 days after the last dose of the study drug

Study Arms (1)

Ibrutinib

EXPERIMENTAL

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

560mg administered orally once daily.

Also known as: PCI-32765, Imbruvica

Ibrutinib

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible:
• Histologically proven marginal zone lymphoma (splenic, nodal and extra-nodal subtypes included). Patients with clinical and histological evidence of large-cell transformation should be excluded from participating in this study
• Prior treatment with one or more lines rituximab or rituximab-based chemoimmunotherapy with failure to achieve at least a partial response (PR) or documented disease progression
• Age ≥ 21 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• At least 1 measurable disease site on computed tomography (CT) scan that is at least 1.5cm in the longest dimension. Lesions that are not well visualized by CT may be measured by magnetic resonance imaging (MRI) instead
• Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[β-hCG\]) at Screening. Women of childbearing potential are defined as sexually mature women who have not undergone a hysterectomy or bilateral tubal ligation or bilateral oopphorectomy or who have not been naturally postmenopausal for \> 2 years
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug. Patient must have an indication for treatment e.g., symptoms from disease, bulky disease (\>5cm), threatened end-organ function, or cytopenias requiring transfusion or growth factor support
• Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
• Adequate hematological and biochemical parameters within 7 days prior to enrollment as defined below:
• Haematological
• Hb ≥8g/dL
• Platelets ≥100,000/mm3 or ≥50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
• Absolute neutrophil count (ANC) ≥1000/mm3 independent of growth factor support
• Biochemical

You may not qualify if:

• Patients who meet any of the following criteria are not eligible
• Prior chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug
• Prior treatment with ibrutinib or other BTK inhibitors or PI3K delta inhibitors
• Concurrent enrolment in another therapeutic investigational clinical treatment study
• Prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed
• Vaccinated with live, attenuated vaccines within 4 weeks of enrollment
• Known central nervous system lymphoma
• History of prior malignancy, except:
• Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated cervical carcinoma in situ without evidence of disease
• History of stroke or intracranial hemorrhage within 6 months prior to enrollment
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
• Requires treatment with strong cytochrome P450(CYP)3A4/5 inhibitors
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrythmias, congestive cardiac failure or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Singapore General Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Tiffany PL Tang

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 28, 2017
• Study Start: July 8, 2016
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)