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CLL/SLLPhase 2CLL-OBGNCT05918276

Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL/SLL

A Phase 2 study testing Orelabrutinib and BG in people with CLL/SLL, run by Nanfang Hospital, Southern Medical University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities. 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 and BG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesChina
Study dates
15 Jul 2023to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 65 years of age and older or between 18 and 65 years of age with severe illness (non-CLL/SLL associated CIRS ≥ 6);
  • ECOG performance status (PS) level 0~2；
  • Expected survival is not less than 12 weeks;
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or histopathology according to IWCLL2008 criteria, and CD20 positive;
  • Meet at least 1 indication for treatment according to IWCLL2008 criteria or Chinese CLL/SLL guidelines 2022
  • Enhanced computed tomography/magnetic resonance imaging (CT/MRI) to detect measurable lesions: at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension; for patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be > 5000/μL (or 5×10^9/L);
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  • Have not received systematic treatment for CLL/SLL in the past;
  • The main organs are functioning normally, the following criteria are met:
  • Routine blood test standards should meet:
  • Absolute neutrophil (ANC) ≥1.0×109/L, platelet (PLT) ≥30×109/L; unless bone marrow and hematopoietic insufficiency is confirmed to be due to CLL/SLL
  • Biochemical examination should meet the following standards:
  • TBIL<2.0× ULN, CLL/SLL liver involvement or confirmed Gilbert syndrome (normal direct bilirubin), total bilirubia ≤ 3 times ULN;
  • ALT and AST <2.5×ULN (ALT and AST <5×ULN for CLL/SLL liver involvement);
  • Endogenous creatinine clearance ≥ 30 ml/min (Cockcroft-Gault formula).
  • Women of childbearing age must have taken reliable contraceptive measures or have taken a pregnancy test (serum or urine) within 7 days prior to enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent to appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug must be agreed;
  • Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.

Who cannot join

  • Patients with 17P- chromosome abnormalities or TP53 mutations;
  • Current or previous biopsy pathology confirms conversion to Richter's syndrome;
  • Have active and uncontrolled autoimmune cytopenias, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;
  • Patients with central nervous system invasion;
  • Glucocorticoid therapy (at a dose equal to or greater than 20 mg/day of prednisone or equivalent) within 14 days prior to the first dose, excluding inhalation, topical medication, intra-articular medication, and prophylaxis before or after iodine contrast use; After discussion with the team leader, higher doses, longer steroid therapy may be allowed in the following cases:
  • treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL disease;
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  • Acute exacerbations due to short-term (within 14 days) use of inactive infections for diseases not associated with CLL/SLL (e.g., arthritis, asthma), including steroid dose adjustment required for adrenal insufficiency;
  • Previous or concurrent uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;
  • Suffering from the following cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval QTc >480ms); According to NYHA standards, grade III.~IV. cardiac insufficiency, or cardiac ultrasound showed left ventricular ejection fraction (LVEF) < 50%;
  • Coagulation dysfunction (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or receiving thrombolysis or anticoagulation therapy;
  • Arteriovenous thrombotic events that occurred within 12 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
  • Known hereditary or acquired bleeding and thrombosis (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
  • Have undergone major surgical procedures or developed severe traumatic injuries, fractures or ulcers within 4 weeks of enrollment;
  • Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
  • Active infection requiring antimicrobial therapy (such as antibacterial drugs and antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment and antifungal treatment);
  • Active hepatitis B (HBV DNA≥2000 IU/mL or 10000 copy number/mL) or hepatitis C (positive for hepatitis C antibodies and HCV RNA above the lower limit of the assay);
  • Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • Have participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;
  • Those who have received strong CYP3A4 inhibitor therapy within 7 days before enrollment, or received strong CYP3A4 inducer therapy within 12 days before participating in the study;
  • Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception; 19. Other circumstances that may affect the conduct of clinical research and the determination of research results as determined by the investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ru Feng, Master contact

+8602061641615

ruth1626@hotmail.com

Xutao Guo, Dr. contact

+8602061641615

gxt827@126.com

China2 sites

  • Hunan Cancer Hospital

    Changsha, Hunan

  • The Central Hospital Of Wuan

    Wuhan, Hubei

    Hongxiang Wang

Other trials in China

About this study

Official title: Exploratory Clinical Study of Orelabrutinib in Combination With BG Regimen in Patients With Naive and Unfit CLL/SLL Without 17p- or TP53 Mutations

This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.

Conditions
CLL/SLL
Being tested
Orelabrutinib and BG
Keywords
Orelabrutinib, bendamustine, obintuzumab

What participants receive

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

  • Orelabrutinib and BGDrug

    Also called OBG

    Drug: Orelabrutinib Orelabrutinib 200mg, po, qd，C2-C7. Twenty-eight days for a cycle.

    Drug: BG Bendamustin 70mg/m2, IV, d2\&d3 inC1, and then d1\&d2 inC2-6.Twenty-eight days for a cycle.

    Obintuzumab 100mg IV, d1, 900mg d2, 1000mg d8\&d15 in C1, and then 1000mg/m2 IV, d1 in C2-6. Twenty-eight days for a cycle.

Study groups in NCT05918276
Study groupRoleWhat they receive
OBGExperimentalNot described
Receives: Drug: Orelabrutinib and BG

What is being measured

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

  1. The rate of CR and uMRD

    The proportion of patients with CR and undetectable peripheral blood/bone marrow minimal residual disease in the end of combination therapy. Patients with CRi are counted as CR.

    Measured: Approximately 2 years.

Secondary outcomes (4)

  1. The rate of CR/CRu and uMRD

    The proportion of patients with CR/CRu and undetectable peripheral blood/bone marrow minimal residual disease in the end of combination therapy. Patients with CRi are counted as CR. CRu is defined as a large spleen size of 16cm or less, and the rest of the indicators meet CR/CRi standards.

    Measured: Approximately 2 years.

  2. The Rate of uMRD

    According to the detection of Shihe Gene [igNGS kit], no residual leukemia cells were detected in a million peripheral blood or bone marrow cells.

    Measured: Approximately 2 years.

  3. PFS（progression-free survival）

    Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.

    Measured: Up to 8 years.

  4. OS（overall survival）

    Overall survival (OS) refers to the time from receiving the first dose to death from any cause.

    Measured: Up to 10 years.

Timeline

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

  1. First posted26 Jun 2023
  2. Study start15 Jul 2023 (estimated)
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05918276
Sponsor's protocol ID
NFEC-2023-202
Acronym
CLL-OBG
Status last verified
Jun 2023
First submitted
8 Jun 2023
Last updated
26 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib and BG in people with CLL/SLL, run by Nanfang Hospital, Southern Medical University at 2 sites 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 16 inclusion and 20 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: opening soon, as of the sponsor's last update on 26 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 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ru Feng, Master (+8602061641615, ruth1626@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of CR and uMRD (time frame: Approximately 2 years.). 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 NCT05918276.

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 26 Jun 2023.

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