Phase IV Observational Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Cell Lymphoma

NCT05920668 | Unknown

• 1 other identifier: CLL2023
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multicenter observational study of Orelabrutinib in the treatment of CLL/SLL. Patients were treated with Orelabrutinib for 12 cycles. The primary end points were grade 3 hypertension and incidence of atrial fibrillation, and the secondary end points were improvement in abnormal markers, ORR,CR,PFS, and OS.

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

• The incidence of Grade 3 hypertension and atrial fibrillation

  Number of patients with grade 3 or above hypertension during treatment/total number of patients enrolled; number of patients with atrial fibrillation during treatment/total number of patients enrolled.

  at the end of 12 cycles of treatment（(each cycle is 28 days)

Secondary Outcomes (6)

• ORR

  at the end of 12 cycles of treatment(each cycle is 28 days)

• CR

  at the end of 12 cycles of treatment(each cycle is 28 days)

• PFS

  From the date of receipt of the first investigational medication to the date of first onset of disease progression or death from any cause, whichever comes first.up to 2 years

• OS

  From the date of receipt of the first study medication to the date of death from any cause.up to 2 years

• Improvement rate of abnormal indicators

  After 12 cycles of treatment(each cycle is 28 days)

Interventions

Orelabrutinib DRUG

Orelabrutinib monotherapy for CLL/SLL 12 cycles

Eligibility Criteria

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

Study Population

Inclusion Criteria:1. Age 18-80 years old, gender unlimited;2. Chronic lymphocytic/small cell leukemia was confirmed by histopathology based on iwCLL criteria;3. According to the iwCLL standard, the treatment can be certified 4.IPI ≥ 25. ECOG score ≤2 points; Exclusion Criteria:1. Patients who have received other BTK inhibitors in the past and have progressed;2. Patients with grade 3 hypertension 3. Patients with atrial fibrillation

You may qualify if:

• \. Age 18-80 years old, gender unlimited; 2. Chronic lymphocytic/small cell leukemia was confirmed by histopathology based on iwCLL criteria; 3. According to the iwCLL standard, the treatment can be certified 4. IPI ≥ 2 5. ECOG score ≤2 points; 6. Measurable lesions detected by enhanced computed tomography/magnetic resonance imaging (CT/MRI) : at least one lymph node with a maximum axis of more than 1.5cm and a measurable vertical dimension; For patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be required. 5000/μL (or 5×10\^9/L); 7. If the major organs are functioning normally, the following criteria are met:
• The standard of blood routine examination shall meet:
• Neutrophil absolute value (ANC) ≥1.0×109/L, platelet (PLT) ≥30×109/L; Unless it is confirmed that the bone marrow and hematopoietic deficiency is caused by CLL/SLL;
• Biochemical examination shall meet the following standards:

You may not qualify if:

• \. Patients who have received other BTK inhibitors in the past and have progressed; 2. Patients with grade 3 hypertension 3. Patients with atrial fibrillation 4. Richter's syndrome is or has been confirmed by biopsy pathology; 5. Has active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura; 6. Present or past malignancies other than cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder carcinoma; 7. Received glucocorticoid therapy (at a dose of 20 mg/ day or higher than prednisone or equivalent) within 14 days prior to initial administration, except for inhalation, topical, intraarticular, and prophylactic use before or after use of iodized contrast agent; After discussion with the group leader, higher doses and longer steroid therapy may be permitted in the following situations:
• Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL disease;
• Short-term (within 14 days) use to treat non-active infections in diseases not associated with CLL/ SRL (e.g., arthritis, asthma) to acute exacerbations, including dose adjustments of steroids required for adrenal insufficiency; 8. Patients who have undergone major surgical operations (tests for diagnostic purposes) or participated in clinical trials of drugs/devices within 4 weeks; 9. Have uncontrolled or significant cardiovascular disease, including:
• <!-- -->
• New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment at the time of screening, left ventricular ejection fraction (LVEF) \&lt in the six months prior to the initial administration of the study drug; 50%;
• Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restricted cardiomyopathy, unestablished cardiomyopathy);
• Clinically significant history of prolonged QTc interphase, or women with interphase QTc in screening period \&gt; 470ms, male \&gt; 450ms;
• Subjects with symptomatic or medicated coronary heart disease;
• Patients with uncontrolled hypertension (on the basis of improving their life style, their blood pressure is still not up to the standard after more than 1 month with the application of reasonably tolerable enough 2 or more antihypertensive drugs (including diuretics), or their blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs); 10. Abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN+4 s or APTT \&gt; 1.5 ULN) or had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or had what the investigator considered a definite tendency to bleed; 11. Arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 12 months before enrollment; 12. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 13. Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Ab positive or HIV positive; 14. Uncontrolled, active systemic fungal, bacterial, viral or other infection (defined as showing persistent signs/symptoms associated with the infection despite no improvement with appropriate antibiotics or other treatment); 15. Allergic disposition or hypersensitivity to obutinib or any other component of the applicable investigational drug; 16. Those who have received potent CYP3A4 inhibitor therapy within 7 days before enrollment, or potent CYP3A4 inducer therapy within 12 days before enrollment, or must also take CYP3A severely inhibiting or strongly inducible drugs; 17. Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 18. Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment; 19. Pregnant and lactating women and subjects of childbearing age who do not want to take contraceptive measures; 20. Poor compliance or inability to follow up regularly; 21. Patients with life-threatening conditions or severe organ dysfunction are deemed unfit to participate in the study; 22. The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of study results.

Sponsors & Collaborators

• Wang Xin: lead

Study Sites (1)

Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib

Central Study Contacts

Mei Ding, PHD

CONTACT

13864151105; dingmei1105@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

CN (1)