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Trial record 50 of 315 for:    IBRUTINIB

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)

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ClinicalTrials.gov Identifier: NCT04062448
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).

Condition or disease Intervention/treatment Phase
Waldenstrom Macroglobulinemia Drug: Ibrutinib Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Combination With Rituximab, in Japanese Patients With Waldenstrom's Macroglobulinemia (WM)
Estimated Study Start Date : September 11, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: Ibrutinib + Rituximab
Participants will receive ibrutinib 420 milligram (mg) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity in combination with rituximab 375 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Weeks 1 to 4 and Weeks 17 to 20.
Drug: Ibrutinib
Ibrutinib 420 mg will be administered orally.
Other Name: PCI-32765

Drug: Rituximab
Rituximab 375 mg/m^2 will be administered intravenously.




Primary Outcome Measures :
  1. Overall Response Rate (ORR) - Assessed by Independent Review Committee (IRC) [ Time Frame: Up to 3.7 years ]
    The ORR is defined as the percentage of participants with complete response (CR), very good partial response (VGPR) or partial response (PR) by IRC assessment.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 3.7 years ]
    PFS is defined as duration from the date of initial dose of ibrutinib to the date of disease progression or death, whichever occurs first.

  2. Pharmacokinetics (PK) of Ibrutinib and its Metabolite PCI-45227 [ Time Frame: Day 1 of Week 4 ]
    Plasma concentration of ibrutinib and its metabolite PCI-45227 will be reported.

  3. Prognostic Biomarkers Relative to Disease and/or Treatment [ Time Frame: Predose (Week 1) ]
    Blood samples will be collected for biomarker analysis that may include myeloid differentiation primary response gene 88 (MYD88), and C-X-C chemokine receptor type 4 (CXCR-4), thought to be prognostic of disease and/or treatment.

  4. Number of Participants with Adverse Events [ Time Frame: Up to 3.7 years ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia (WM) in accordance with the consensus panel of the second International Workshop on Waldenstrom's Macroglobulinemia (IWWM)
  • Japanese participants with treatment naïve or relapsed/refractory WM
  • Measurable disease defined as serum monoclonal immunoglobulin M (IgM) greater than (>) 0.5 gram per deciliter (g/dL)
  • Symptomatic disease, requiring treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 2
  • Hematology and biochemical values within protocol-defined limits
  • Female participants of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective methods of contraception while taking study drug. Women of childbearing potential must be practicing a highly effective, preferably user independent method of birth control during treatment with any drug in this study and for up to 12 months after the last dose of rituximab, 3 months after last dose of ibrutinib. Male participants must use an effective barrier method of contraception during the study and after receiving the last dose of ibrutinib, and for up to 12 months after last dose of rituximab if sexually active with a female of childbearing potential
  • Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

  • Involvement of the central nervous system by WM
  • Prior exposure to ibrutinib or other Bruton's Tyrosine Kinase (BTK) inhibitors
  • Rituximab treatment within the last 12 months before the first dose of study intervention
  • Received any WM-related therapy <=30 days prior to first administration of study treatment
  • Received a prior allogeneic hematopoietic stem cell transplant
  • Plasmapheresis less than (<) 35 days prior to the initiation of study drug, except when at least one serum IgM central assessment was performed during the screening period and was >35 days from the most recent plasmapheresis procedure
  • History of other malignancies
  • Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug
  • Infection requiring systemic treatment that was completed <=14 days before the first dose of study drug
  • Currently active, clinically significant Child-Pugh Class B or C hepatic impairment
  • Inability or difficulty swallowing capsules, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function
  • Stroke or intracranial hemorrhage within 12 months prior to enrollment
  • Currently active, clinically significant cardiovascular disease
  • Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
  • Infection with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C virus
  • Major surgery within 4 weeks of first dose of study drug
  • Lactating or pregnant
  • Male participants who plan to father a child while enrolled in this study or within 3 months after the last dose of ibrutinib, and within 12 months after last dose of rituximab
  • Any contraindication to ibrutinib or rituximab including hypersensitivity to the active substance or to any of the excipients of ibrutinib or rituximab per local prescribing information
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study intervention or is currently enrolled in an investigational study
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg [for example], compromise the wellbeing) or that could prevent, limit, or confound the protocol-specified assessments
  • Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

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): NCT04062448


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Japan
National Cancer Center Hospital Not yet recruiting
Chuo-ku, Japan, 104-0045
Kameda Medical Center Not yet recruiting
Kamogawa City, Japan, 296-8602
National Hospital Organization Kumamoto Medical Center Not yet recruiting
Kumamoto-City, Japan, 860-0008
Matsuyama Red Cross Hospital Not yet recruiting
Matsuyama-City, Japan, 790-8524
Nagoya City University Hospital Not yet recruiting
Nagoya-City, Japan, 467-8602
Osaka City University Hospital Not yet recruiting
Osaka-City, Japan, 545-8586
Osaka University Hospital Not yet recruiting
Suita-City, Japan, 565-0871
NHO Disaster Medical Center Not yet recruiting
Tachikawa, Japan, 190-0014
University of Tsukuba Hospital Not yet recruiting
Tsukuba-City, Japan, 305-8576
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04062448     History of Changes
Other Study ID Numbers: CR108666
54179060WAL2002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents