Evaluating orelabrutinib for CLL/SLL patients not responding well to ibrutinib
A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib
This study is testing if switching to a new medication called orelabrutinib can help people with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma who aren't doing well on their current treatment with ibrutinib.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | ibrutinib, orelabrutinib |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT05491044 on ClinicalTrials.gov |
What this trial studies
This study is a single-arm, multi-center evaluation of orelabrutinib's efficacy and safety in patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who are slowly responding to ibrutinib. Eligible patients will switch from ibrutinib to orelabrutinib, receiving a daily oral dose of 150mg for up to two years or until certain endpoints are met, such as disease progression or intolerable side effects. The study aims to determine if orelabrutinib can provide a better response in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with CLL/SLL who have shown only stable disease after three cycles of ibrutinib.
Not a fit: Patients with active disease progression on ibrutinib or those with CNS involvement by CLL will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for CLL/SLL patients who are not adequately responding to current therapies.
How similar studies have performed: While this approach is novel in the context of switching to orelabrutinib, similar studies have shown promise in evaluating alternative therapies for patients with inadequate responses to existing treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.
Where this trial is running
Beijing, Beijing and 1 other locations
- Department of Hematology, Peking University People's Hospital — Beijing, Beijing, China (Not_yet_recruiting)
- Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Shenmiao Yang — Peking University People's Hospital
- Study coordinator: Shenmiao Yang
- Email: yangshenmiao@hotmail.com
- Phone: +8601088326666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.