- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042376
A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)
March 26, 2024 updated by: Janssen Research & Development, LLC
A Single Arm, Multicenter, Phase 4 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Chinese Subjects With Relapse or Refractory Waldenström's Macroglobulinemia
The purpose of this study is to evaluate the efficacy of ibrutinib based on overall response rate (ORR) (partial response [PR] or better) by investigator assessment per the modified Consensus Response Criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (NCCN 2019), in Chinese participants with relapsed or refractory waldenstrom's macroglobulinemia.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Changchun, China, 130021
- The First Hospital of Jilin University
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Hangzhou, China, 310003
- First affiliated Hospital of Zhejiang University
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Tianjin, China, 300320
- Institute of Hematology & Blood Diseases Hospital
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Wuhan, China, 430023
- Wuhan Union Hospital
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Xi'an, China, 710004
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Men and women greater than or equal to (>=) 18 years of age
- Eastern Cooperative Oncology Group (ECOG) less than or equal to (<=) 2
- Previously received at least one prior therapy for WM and have had either documented disease progression or had no response to the most recent treatment regimen
- Centrally confirmed clinicopathological diagnosis of WM
- Measurable disease defined as serum monoclonal immunoglobulin M (IgM) >0.5 gram per deciliter (g/dL)
- Symptomatic disease, requiring treatment
- 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. Female participants of childbearing potential should avoid becoming pregnant while taking ibrutinib and for up to 1 month after the last dose of study drug. Male participants must use an effective barrier method of contraception during the study and for 3 months following the last dose of ibrutinib if sexually active with a female of childbearing potential
Exclusion Criteria:
- Involvement of the central nervous system by WM
- Evidence of disease transformation
- Prior exposure to BTK inhibitors
- Known hypersensitivity reaction to ibrutinib or to the excipients in its formulation
- Received any WM-related therapy <=30 days prior to first administration of study treatment
- Received a prior allogeneic hematopoietic stem cell transplant
- Plasmapheresis <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, except: (a) malignancy treated with curative intent and with no known active disease present for >=2 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician; (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease; (c) adequately treated carcinoma in situ without evidence of disease
- 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
- Bleeding disorders or hemophilia
- Stroke or intracranial hemorrhage within 6 months prior to enrollment
- Infection with human immunodeficiency virus (HIV) or active infection with hepatitis B or hepatitis C
- Major surgery within 4 weeks of first dose of study drug
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the participant's safety or put the study outcomes at undue risk
- Currently active, clinically significant hepatic impairment Child-Pugh Class B or C according to the Child Pugh classification
- Currently active, clinically significant cardiovascular disease
- Requires or receiving anticoagulation with warfarin or other Vitamin K antagonists
- Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- Lactating or pregnant
- Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local participant privacy regulations)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ibrutinib 420 milligram (mg)
Participants will receive ibrutinib 420 mg once daily, continuously starting at Day 1 of Week 1 until disease progression or unacceptable toxicity, whichever occurs first.
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Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg*3 capsules taken together at one time).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: Up to 4 years
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ORR is defined as the percentage of participants who achieve partial response (PR) or better per the modified Consensus Response Criteria from the 6th International Workshop on Waldenstrom Macroglobulinemia (IWWM) (NCCN 2019) as assessed by the investigator.
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Up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Clinical Response Rate (CRR)
Time Frame: Up to 4 years
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CRR is defined as the percentage of participants who achieve minor response (MR) or better according to the modified 4th IWWM (NCCN 2019) criteria as assessed by the investigator.
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Up to 4 years
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Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response
Time Frame: Up to 4 years
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VGPR or better rate is defined as the percentage of participants who achieve VGPR or better according to the modified 4th IWWM (NCCN 2019) criteria as assessed by the investigator.
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Up to 4 years
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Duration of Response (DOR)
Time Frame: Up to 4 years
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DOR is defined as duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease or death for responders (PR or better) as assessed by the investigator.
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Up to 4 years
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Time to Response (TTR)
Time Frame: Up to 4 years
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TTR is defined as the time from the date of first dose to the date of initial documentation of a response (PR or better).
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Up to 4 years
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Progression Free Survival (PFS)
Time Frame: Up to 4 years
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PFS is defined as duration from the date of first dose to the date of disease progression or death, whichever is first reported, assessed according to the modified 6th IWWM (NCCN 2019) criteria.
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Up to 4 years
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Overall Survival (OS)
Time Frame: Up to 4 years
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OS is defined as the time from the date of first dose to the date of the participant's death from any cause.
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Up to 4 years
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Trough Plasma Concentration (Ctrough) of Ibrutinib
Time Frame: Day 1 of Weeks 1, 5 and 9
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Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
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Day 1 of Weeks 1, 5 and 9
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Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: Up to 4 years
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Up to 4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2019
Primary Completion (Estimated)
March 29, 2024
Study Completion (Estimated)
March 29, 2024
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Waldenstrom Macroglobulinemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Tyrosine Kinase Inhibitors
- Ibrutinib
Other Study ID Numbers
- CR108654
- 54179060WAL4001 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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