Idiopathic Multicentric Castleman's DiseasePhase 2iMCDNCT04743687
Zanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial
A Phase 2 study testing Zanubrutinib in people with Idiopathic Multicentric Castleman's Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Multicentric Castleman's Disease
- What is being tested?
- Zanubrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fulfilled the CDCN (Castleman Disease Collaborative Network) diagnostic criteria of iMCD
- relapsed or refractory disease. Relapsed = patients who ever achieved overall partial response (PR) or complete response (CR) with prior lines of therapy suffered from progressive disease (PD); refractory = iMCD patients who never achieved PR or CR with the first-line treatment but suffered from PD during treatment.
- Eastern Cooperative Oncology Group performance status (ECOG-PS ≤ 2)
- Neutrophil count ≥ 0.75×10^9/L, hemoglobin ≥ 70 g/L and platelet count > 30×10^9/L
- Total bilirubin ≤ 2 x ULN (upper limit of normal), AST（aspartate aminotransferase） or ALT（Alanine aminotransferase）≤ 2.5 x ULN
- INR （international normalized ratio) and APTT(activated partial thromboplastin time) ≤ 1.5 x ULN；eGFR>25ml/min/1.73m2
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- estimated survival ≥ 3 months
- agree to take birth control methods during study period for women of reproductive age
- agree to provide informed consent
Who cannot join
- concurrent malignancies
- prior history of receiving any kind of BTK (Bruton's tyrosine kinase) inhibitors
- patients with SLE (systemic lupus erythematosus), HHV-8 (human herpesvirus-8) infection or POEMS syndrome
- History of major surgery or radiation therapy within 4 weeks before initiation of study drug
- history of myocardial infarction within 1 years
- patient with history of heart failure (NYHA 3 or 4) would be excluded unless his LVEF(left ventricular ejection fraction) ≥ 50% within 1 months
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- primary cardiomyopathy; Qtc > 450ms for men and > 470ms for women
- breast feeding or pregnant women
- intolerance for oral regimen due to gastro-intestinal disorders
- uncontrolled infection
- positive HBV(hepatitis B virus)-DNA titers or positive HbsAg; positive HCV(hepatitis C virus)antibody; patients with HIV infection
- patients with history of bleeding disorders
- cerebral infarction or intracranial bleeding within 6 months
- active bleeding disorders within 2 months
- taking anti-platelet or anticoagulation drugs
- taking drugs which strongly inhibit P450 CYP3A
- patients or their relatives fail to understand the purpose of the study
- any other conditions that the investigators consider to be not appropriate for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Jian Li, M.D., +86-18610852525, lijian@pumch.cn
Lu Zhang, M.D., +86-18610728815, pumczhanglu@163.com
About this study
Official title: The Efficacy and Safety of Zanuburutinib in Relapsed and Refractory Idiopathic Multicentric Castleman Disease (iMCD): a Prospective, Single-center, Single-arm Trial
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.
Read the detailed description
This is a single center, open-labeled , single arm, prospective study which includes a safety run-in phase. The primary endpoint is the overall response rate which includes complete response (CR) and partial response (PR) at Week 12 and Week 24. The secondary endpoints include progression-free survival (PFS), overall survival (OS), and adverse events. There are two phases of the study. The first phase is the 'safety run-in phase'which plans to enroll 6 patients who would be observed for safety issues for 12 weeks after study drug administration. If no Grade ≥ 4 (CTCAE) adverse events (AE) occurs during this phase, the study would enter the second phase; if Grade ≥ 4 (CTCAE) AE happens during this phase, the study would be terminated. In the second phase of the study, another 24 patients would be enrolled. All enrolled patients would receive the study drug until progression of disease, intolerability of the drugs or Week 96 and would be followed every 4 weeks in the first 12 weeks, every 12 weeks until Week 48 and every 24 weeks until Week 96. The follow-up phase to assess PFS and OS will last from initiation of study drug to 36 months after enrollment (evaluation would be carried out every 24 weeks after Week 96). The total study duration will be 4 years after the last patient starts study medication.
- Being tested
- Zanubrutinib
- Keywords
- iMCD, Zanuburutinib, efficacy, safety
- Medical subject headings
- Multi-centric Castleman's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called brukinsa
Oral Zanuburutinib, 160mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Zanuburutinib | Experimental | Oral Zanuburutinib 160mg twice a day Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) at Week 12
Overall response (including partial response and complete response) rate at week 12 after zanuburutinib therapy
Measured: From date of treatment initiation to 12 weeks after treatment
Overall response rate (ORR) at Week 24
Overall response (including partial response and complete response) rate at week 24 after zanuburutinib therapy
Measured: From date of treatment initiation to 24 weeks after treatment
Secondary outcomes (3)
Progression free survival
Time to disease progression or death
Measured: From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Overall survival
Time to death
Measured: From date of treatment initiation until the date of death from any cause, whichever came first, assessed up to 36 months
Number of Participants With Treatment-related Adverse Events
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)
Measured: From initiation study regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Multicentric Castleman's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a single center, single arm, phase 2 study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743687
- Sponsor's protocol ID
- ZS-2551
- Acronym
- iMCD
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Gao YH, Li SY, Zhao H, Zhang MY, Yu YY, Liu YT, Li J. A prospective study of zanubrutinib, a Bruton tyrosine kinase inhibitor, in relapsed/refractory idiopathic multicentric Castleman disease. Int J Hematol. 2024 Jun;119(6):631-637. doi: 10.1007/s12185-024-03747-7. Epub 2024 Mar 28.
PubMed 38546960