CLL/SLLPhase 2NCT05491044
A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib
A Phase 2 study testing orelabrutinib in people with CLL/SLL, run by Peking University People's Hospital at 2 sites in China.
Trial summary
This is a single arm, multi-center study to evaluate the efficacy and safety of orelabrutinib for Chronic lymphocytic lymphoma（CLL)/small lymphocytic lymphoma (SLL) patients who are slowly responding to Ibrutinib switched to Orelabrutinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL/SLL
- What is being tested?
- orelabrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2022to 30 Aug 2024
- 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
- Age ≥18 years old， male or female
- Diagnosed as CLL/SLL based on iwCLL2018 criteria
- Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
- ECOG score 0-2
- Slowly responding to ibrutinib is defined as: patients only achieve SD after 3 cycles of ibrutinib treatment
- Life expectancy ≥6 months
- Adequate bone marrow reserve and adequate organ function
- Participant or his/her legal agent must be willing to sign a written informed consent document.
Who cannot join
- Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy.
- CNS involvement by CLL
- Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
- Uncontrolled or significant cardiovascular disease
- Active hemorrhage within 2 months prior screening
- Cerebral ischemic stroke or bleeding within 6 months prior screening
Show all 17Show fewer
- Other surgery history within 6 weeks prior screening
- Uncontrolled active systemic fungal, bacterial, virus or other microbe infection, or intravenous injection of antibiotics needed
- Anti-tumor corticosteroids treatment 1 week prior orelabrutinib and anti-tumor herbal medicine treatment within 4 weeks prior screening
- Activated or uncontrolled hepatitis virus B infection (HBsAg positive with/or HBc Ab positive and HBV-DNA titration positive), HCV-RNA positive, HIV positive.
- Accepted live vaccine or immunization within 4 weeks prior screening
- Medium / strong inhibition or induction of cytochrome P450 CYP3A is needed.
- Allergy to orelabrutinib or the subsidiary (or supplementary) material (Hydroxypropyl methylcellulose acetate succinate, mannitol, cross-linked sodium carboxymethylcellulose, hydroxypropyl cellulose, silica and magnesium stearate)
- Obvious gastro-bowel disease which may influence the intaking, transportation or absorption of the drug, or total gastrectomy.
- Pregnant or breeding women, or women of childbearing age who are unwilling to take contraceptive measures during the whole study period and within 180 days after the last administration of the study drug; non surgically sterilized men who are unwilling to take contraceptive measures during the whole study period and within 180 days of the last administration of the study drug.
- Potentially life-threatening situation, or severe organ dysfunction, or situations the researchers think not suitable for the trial
- Any mental or cognitive impairment which may limit the understanding and implementation of informed consent or the compliance with the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Department of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaojun Huang, +8601088326666, xjhrm@medmail.com.cn
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shenmiao Yang, MD
About this study
This is a single arm, multi-center study to evaluate the efficacy and safety of orelabrutinib for Chronic lymphocytic lymphoma（CLL)/small lymphocytic lymphoma (SLL) patients who are slowly responding to Ibrutinib switched to Orelabrutinib.
Read the detailed description
The eligible CLL/SLL patients who are slowly responding to Ibrutinib will be switched to Orelabrutinib treatment. The patients will receive Orelabrutinib 150mg oral daily (28 days/cycle) for up to 2 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).
- Conditions
- CLL/SLL
- Being tested
- orelabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orelabrutinibDrug
Orelabrutinib 150mg po qd d1-28, up to 2 years or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| orelabrutinib | Experimental | CLL/SLL patients who are slowly responding to ibrutinib are switched to orelabrutinib. Receives: Drug: orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR at cycle 3 after switched to orelabrutinib
Overall response rate is defined as the proportion of patients with a best response of CR/CRi and PR/PR-L
Measured: at cycle 3 (28 days/cycle)
Secondary outcomes (3)
DOR
The time from the first assessment of CR/CRi or PR/PR-L to progressive disease or death (due to any cause).
Measured: Up to 2 years
PFS
Progression-free survival is calculated from the date of start of therapy until the date of first documented progress or death due to any cause.
Measured: Up to 2 years
OS
Overall survival is defined as the duration from start of treatment to time of death.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jan 2022
- Primary completion28 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL/SLLStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Shenmiao Yang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491044
- Sponsor's protocol ID
- Slowly responding switch IIT
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2022
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib
- ClinicalTrials.gov ID
- NCT05491044
- Acronym / sponsor ID
- Slowly responding switch IIT
- Conditions
- CLL/SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 8 Aug 2022 (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.
This is a single arm, multi-center study to evaluate the efficacy and safety of orelabrutinib for Chronic lymphocytic lymphoma（CLL)/small lymphocytic lymphoma (SLL) patients who are slowly responding to Ibrutinib switched to Orelabrutinib.
Detailed description
The eligible CLL/SLL patients who are slowly responding to Ibrutinib will be switched to Orelabrutinib treatment. The patients will receive Orelabrutinib 150mg oral daily (28 days/cycle) for up to 2 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orelabrutinib | Experimental | Drug: orelabrutinibCLL/SLL patients who are slowly responding to ibrutinib are switched to orelabrutinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old， male or female
- Diagnosed as CLL/SLL based on iwCLL2018 criteria
- Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
- ECOG score 0-2
- Slowly responding to ibrutinib is defined as: patients only achieve SD after 3 cycles of ibrutinib treatment
Key exclusion criteria (17 listed)
- Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy.
- CNS involvement by CLL
- Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
- Uncontrolled or significant cardiovascular disease
- Active hemorrhage within 2 months prior screening
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 |
|---|---|---|
| orelabrutinibOrelabrutinib 150mg po qd d1-28, up to 2 years or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first). | Drug | orelabrutinib |
Primary outcome
ORR at cycle 3 after switched to orelabrutinib
Time frame: at cycle 3 (28 days/cycle)
Overall response rate is defined as the proportion of patients with a best response of CR/CRi and PR/PR-L
3 secondary outcomes
DOR
Time frame: Up to 2 years
PFS
Time frame: Up to 2 years
OS
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
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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.
Shenmiao Yang principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing orelabrutinib in people with CLL/SLL, run by Peking University People's Hospital at 2 sites 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 8 inclusion and 17 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Shenmiao Yang (+8601088326666, yangshenmiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR at cycle 3 after switched to orelabrutinib (time frame: at cycle 3 (28 days/cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2023.