Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03093831
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Singapore General Hospital
Samsung Medical Center
Information provided by (Responsible Party):
National Cancer Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell, Marginal Zone Drug: Ibrutinib Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Investigator Sponsored Multi-Centre Trial of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Patients With Relapsed or Refractory Marginal Zone Lymphoma
Study Start Date : July 8, 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibrutinib

Arm Intervention/treatment
Experimental: Ibrutinib Drug: Ibrutinib
560mg administered orally once daily.
Other Names:
  • PCI-32765
  • Imbruvica




Primary Outcome Measures :
  1. Overall Response Rates [ Time Frame: From time of first study drug administration until best overall response of CR or PR is achieved, up to 3 years ]
    Proportion of patients who achieve either a Complete Response (CR) or Partial Response (PR) as best response


Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: From time of first study drug administration until first occurence of disease progression or death from any cause, up to 3 years ]
  2. Overall Survival [ Time Frame: From time of first study drug administration until death from any cause, up to 3 years ]
  3. Frequency and severity of adverse events [ Time Frame: From the time the ICF is signed until 30 days after the last dose of the study drug ]
  4. Frequency of adverse events requiring discontinuation of study drug or dose reductions [ Time Frame: From the time the ICF is signed until 30 days after the last dose of the study drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN)
  • Total bilirubin ≤1.5 x ULN (unless elevated bilirubin is non-hepatic in origin or due to Gilbert's syndrome)
  • Serum creatinine ≤2 x ULN or estimate glomerular filtration rate (GFR)(Cockroft Gault) ≥ 40 mL/min/1.73m2

Exclusion Criteria:

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
  • Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, or corrected QT interval (QTc) ≥470 msec
  • Known history of Human Immunodeficiency Virus (HIV), or active Hepatitis C or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
  • Pregnant or lactating women
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093831


Contacts
Layout table for location contacts
Contact: Tze Wei Lim +65 6436 8000 lim.tze.wei@nccs.com.sg
Contact: Stella Chan +65 6436 8000 stella.chan.l.l@nccs.com.sg

Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center Withdrawn
Seoul, Korea, Republic of
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Xiu Ping Chue    +65 6576 2687    chue.xiu.ping@sgh.com.sg   
Principal Investigator: Yuh Shan Lee         
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Singapore General Hospital
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Tiffany PL Tang National Cancer Centre, Singapore

Layout table for additonal information
Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03093831     History of Changes
Other Study ID Numbers: 54179060LYM2009
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin