A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)

NCT04042376 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: CR10865454179060WAL4001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

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.

Conditions

Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR was defined as the percentage of participants who achieved partial response (PR) or better (VGPR) per the modified consensus response criteria from sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) (National Comprehensive Cancer Network \[NCCN\], 2019). PR: greater than or equal to (\>=) 50 percent (%) reduction of serum immunoglobulin M (IgM) from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. Very Good Partial Response (VGPR): \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.

  From start of the treatment (Day 1) up to 49.3 months

Secondary Outcomes (8)

• Clinical Response Rate (CRR)

  From start of the treatment (Day 1) up to 49.3 months

• Very Good Partial Response (VGPR) or Better Response Rate

  From start of the treatment (Day 1) up to 49.3 months

• Duration of Response (DOR)

  From the date of first documented response up to date of first documented PD or death (Day 1 up to 49.3 months)

• Time to Response (TTR)

  From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months)

• Progression Free Survival (PFS)

  From day of first dose (Day 1) until PD or death (up to 49.3 months)

Study Arms (1)

Ibrutinib 420 milligram (mg)

EXPERIMENTAL

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.

Drug: Ibrutinib

Interventions

Ibrutinib DRUG

Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg\*3 capsules taken together at one time).

Also known as: JNJ-54179060, PCI-32765

Ibrutinib 420 milligram (mg)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

The First Hospital of Jilin University

Changchun, 130021, China

Location

First affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Institute of Hematology and Blood Diseases Hospital

Tianjin, 300320, China

Location

Wuhan Union Hospital

Wuhan, 430023, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Related Publications (1)

• Yi S, Cai Z, Hu Y, He A, Gao S, Li Q, Sha L, Zhang N, Ren Y, Gai X, Yang X, Qin R, Qiu L. Ibrutinib Efficacy, Safety, and Pharmacokinetics in Chinese Patients with Relapsed or Refractory Waldenstrom's Macroglobulinemia: A Multicenter, Single-Arm, Phase 4 Study. Adv Ther. 2024 Feb;41(2):672-685. doi: 10.1007/s12325-023-02720-w. Epub 2023 Dec 11.

  PMID: 38079089 DERIVED

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Executive Medical Director Onc
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 1, 2019
• Study Start: December 18, 2019
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: May 25, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)