Brief Title
A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)
Official Title
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
Brief Summary
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Overall Response Rate (ORR)
Secondary Outcome
Percentage of Participants Achieving Clinical Response Rate (CRR)
Condition
Waldenstrom Macroglobulinemia
Intervention
Ibrutinib
Study Arms / Comparison Groups
Ibrutinib 420 milligram (mg)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
17
Start Date
December 18, 2019
Completion Date
March 29, 2024
Primary Completion Date
December 31, 2023
Eligibility Criteria
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Janssen Research & Development, LLC Clinical Trial, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04042376
Organization ID
CR108654
Secondary IDs
54179060WAL4001
Responsible Party
Sponsor
Study Sponsor
Janssen Research & Development, LLC
Study Sponsor
Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC
Verification Date
March 2023