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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Zanuburutinib in Relapsed and Refractory Idiopathic Multicentric Castleman Disease (iMCD): a Prospective, Single-center, Single-arm Trial
- ClinicalTrials.gov ID
- NCT04743687
- Acronym / sponsor ID
- iMCD / ZS-2551
- Keywords
- iMCD, Zanuburutinib, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effectiveness and safety of Zanuburutinib in relapsed and refractory idiopathic Multicentric Castleman's disease (iMCD) patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a single center, single arm, phase 2 study.
| Arm | Type | Receives |
|---|---|---|
| Zanuburutinib | Experimental | Drug: ZanubrutinibOral Zanuburutinib 160mg twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: brukinsaOral Zanuburutinib, 160mg twice a day | Drug | Zanuburutinib |
Primary outcome
Overall response rate (ORR) at Week 12
Time frame: From date of treatment initiation to 12 weeks after treatment
Overall response (including partial response and complete response) rate at week 12 after zanuburutinib therapy
Overall response rate (ORR) at Week 24
Time frame: From date of treatment initiation to 24 weeks after treatment
Overall response (including partial response and complete response) rate at week 24 after zanuburutinib therapy
3 secondary outcomes
Progression free survival
Time frame: 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 frame: 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
Time frame: From initiation study regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 38546960Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Li, M.D. (+86-18610852525, lijian@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) at Week 12 (time frame: From date of treatment initiation to 12 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.