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CLL/SLLNCT05920668

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

An observational study of CLL/SLL, run by Wang Xin at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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
How many people
20 participants
Where
1 siteChina
Study dates
1 Jul 2023to 1 Jul 2025
Phase
Observational
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

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

Who may be able to join

  • 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 ≥ 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:
  • TBIL < 2.0×ULN, CLL/SLL involved liver or diagnosed Gilbert syndrome (normal direct bilirubin), total bile red ≤ 3 ULN; ALT and AST < 2.5×ULN (for CLL/SLL involved liver, ALT and AST < 5×ULN); Endogenous creatinine clearance ≥30ml/min (Cockcroft-Gault formula). 8. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 9. Expected survival > 6 months; 10. Patients voluntarily participated in this study and signed written informed consent.

Who cannot join

  • 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 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

Mei Ding, PHD contact

13864151105

dingmei1105@sina.com

China1 site, 1 recruiting

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

    Jinan, Shandong, 250021

    Xin Wang, MD, PHD, 86-531-68778331, xinw007@126.com

    Mei Ding, MD, PHD, 13864151105, dingmei1105@sina.com

    Recruiting

Other trials in China

About this study

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
Being tested
Orelabrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrelabrutinibDrug

    Orelabrutinib monotherapy for CLL/SLL 12 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. ORR

    Objective Response Rate

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

  2. CR

    complete response

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

  3. PFS

    progression-free survival

    Measured: 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

  4. OS

    Overall Survival

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

  5. Improvement rate of abnormal indicators

    Continuous improvement in hematology (hemoglobin level increased to greater than 110g /L or ≥20 g/L increase from baseline, or platelet count increased to ≥50% from baseline, without blood transfusion/growth factors)

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

  6. QoL

    Quality of Life score

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920668
Sponsor's protocol ID
CLL2023
Status last verified
Jun 2023
First submitted
5 Jun 2023
Last updated
27 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of CLL/SLL, run by Wang Xin at 1 site 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 5 inclusion and 9 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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 Mei Ding, PHD (13864151105, dingmei1105@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of Grade 3 hypertension and atrial fibrillation (time frame: at the end of 12 cycles of treatment（(each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920668.

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 27 Jun 2023.

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