A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib

NCT05491044 | Unknown Phase 2

• 1 other identifier: Slowly responding switch IIT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

• 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

  at cycle 3 (28 days/cycle)

Secondary Outcomes (3)

• DOR

  Up to 2 years

• PFS

  Up to 2 years

• OS

  Up to 2 years

Other Outcomes (1)

• BTK occupancy

  Before taking orelabrutinib and take orelabrutinib for 3-6 cycles

Study Arms (1)

orelabrutinib

EXPERIMENTAL

CLL/SLL patients who are slowly responding to ibrutinib are switched to orelabrutinib.

Drug: orelabrutinib

Interventions

orelabrutinib DRUG

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).

orelabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (2)

Department of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib

Study Officials

• Shenmiao Yang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenmiao Yang

CONTACT

+8601088326666; yangshenmiao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hematology

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: January 1, 2022
• Primary Completion: August 28, 2024
• Study Completion: August 30, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)