A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib
Overview
- Phase
- Phase 2
- Intervention
- orelabrutinib
- Conditions
- CLL/SLL
- Sponsor
- Peking University People's Hospital
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- ORR at cycle 3 after switched to orelabrutinib
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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).
Investigators
Xiao-Jun Huang
Head of Hematology
Peking University People's Hospital
Eligibility 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.
Arms & Interventions
orelabrutinib
CLL/SLL patients who are slowly responding to ibrutinib are switched to orelabrutinib.
Intervention: orelabrutinib
Outcomes
Primary Outcomes
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
Secondary Outcomes
- DOR(Up to 2 years)
- OS(Up to 2 years)
- PFS(Up to 2 years)