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Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (ZEN-CLL)

2026년 9월 9일 업데이트: The Lymphoma Academic Research Organisation

ZEN-CLL - A Phase II Trial Evaluating Zanubrutinib in Elderly, Treatment-Naïve, CLL Patients

This phase II, open-label, multicenter study evaluates zanubrutinib in patients aged 80 years and older with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who require treatment.

CLL and SLL are slow-growing blood cancers that mainly affect older adults. Although zanubrutinib is an effective treatment, taking it continuously at the full dose may increase the risk of side effects over time, particularly in elderly patients. The study aims to assess whether a planned reduction in the dose of zanubrutinib after an initial period of treatment can maintain disease control while improving long-term tolerability.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

The ZEN-CLL study is evaluating a treatment strategy based on zanubrutinib in previously untreated elderly patients with CLL or small lymphocytic lymphoma (SLL). Approximately 95 participants will be enrolled in 17 LYSA centers in France.

All participants will receive zanubrutinib 160 mg twice daily for the first 18 months of treatment. After Month 18, the dose will be reduced according to the dose received at that time and the participant's tolerability. Treatment will continue until permanent treatment discontinuation or the end of study participation.

The study aims to determine whether this dose reduction strategy can maintain disease control while improving long-term tolerability in this elderly population.

연구 유형

중재적

등록 (추정된)

95

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Project management
  • 전화번호: +33 4 72 66 93 33
  • 이메일: zen-cll@lysarc.org

연구 장소

  • 프랑스
      • Argenteuil, 프랑스, 95107
      • Avignon, 프랑스, 84000
        • Ch D'Avignon - Hopital Henri Duffaut
        • 연락하다:
        • 수석 연구원:
          • Safia CHEBREK, doctor
      • Bayonne, 프랑스, 64109
        • CH de la Côte Basque
        • 연락하다:
        • 수석 연구원:
          • Nathan MOTTAL, doctor
      • Bordeaux, 프랑스, 33076
      • Cergy-Pontoise, 프랑스, 95303
      • Corbeil-Essonnes, 프랑스, 91106
        • Ch Sud Francilien
        • 연락하다:
        • 수석 연구원:
          • Laurence SIMON, doctor
      • Estaing, 프랑스, - SITE ESTAING
      • Grenoble, 프랑스, 38700
        • CHU de GRENOBLE
        • 연락하다:
        • 수석 연구원:
          • Lysiane MOLINA, doctor
      • Le Chesnay, 프랑스, 78157
        • Ch de Versailles - Hopital Andre Mignot
        • 연락하다:
        • 수석 연구원:
          • Fatiha MERABET, doctor
      • Le Mans, 프랑스, 72000
        • Ch Du Mans-Centre de Cancerologie de La Sarthe
        • 연락하다:
        • 수석 연구원:
          • Kamel LARIBI, doctor
      • Lille, 프랑스, 59020
        • Hopital Saint Vincent-de-Paul
        • 연락하다:
        • 수석 연구원:
          • Bénédicte HIVERT, doctor
      • Lyon, 프랑스, 69373
      • Orléans, 프랑스, 45067
      • Rouen, 프랑스, 76038
      • Toulouse, 프랑스, 31059
      • Vandœuvre-lès-Nancy, 프랑스, 54511
        • CHRU Nancy - hôpital Brabois
        • 연락하다:
        • 수석 연구원:
          • Pierre FEUGIER, professor
    • Pierre Bénite
      • Lyon, Pierre Bénite, 프랑스, 69310

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Participant who understands and voluntarily signs and dates an informed consent form prior to any studyspecific assessments/procedures being conducted, including consent for specific biology analysis
  • Must be able to adhere to the trial visit schedule and other protocol requirements
  • ≥ 80 years at the time of signing the informed consent form (ICF) with no upper age limit
  • Previously untreated and documented CLL or small lymphocytic lymphoma (SLL), with a Royal Marsden Hospital (RMH) or Matutes Score of 4 or 5. For SLL a detectable clone with a CLL phenotype in the peripheral blood is a prerequisite for trial participation.
  • Participant requiring treatment according to 2018 IWCLL guidelines
  • ECOG performance status 0 to 2
  • Life expectancy > 6 months

  • Adequate hematopoietic function within 7 days before the participant's enrollment

    • ANC ≥ 0.75 G/L
    • And Platelets ≥ 50 G/L Note: Platelets transfusions may be administered during screening to meet this requirement
  • Hemoglobin level > 9g/dL, regardless of transfusion
  • Adequate renal function defined by a Creatinine Clearance ≥ 30 ml/min calculated according to MDRD or CKD-EPI or Cockcroft-Gault (using actual body weight).
  • Adequate liver function, as indicated by a total bilirubin <1.5 x ULN, AST and ALT <3 x ULN value, unless directly attributed to the participant's CLL/SLL or to Gilbert's Syndrome (the ULN is based on institutionalvalues)
  • Participant covered by any social security system
  • Participant who understands and speaks the country official language unless local regulation authorizes independent translator

Exclusion Criteria:

  • Any prior CLL or SLL-specific therapies, even including rituximab used for autoimmune cytopenias.

  • Clinically significant cardiovascular disease including the following:

    1. Myocardial infarction within 6 months prior to ICF signature
    2. Unstable angina within 3 months prior to ICF signature
    3. NYHA class III or IV heart failure
    4. Uncontrolled hypertension
    5. History of clinically significant arrhythmias (including sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
    6. History of Mobitz II second- or third-degree heart block without permanent pacemaker
    7. Known LVEF <50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
  • Child-Pugh liver cirrhosis
  • Clinical evidence for Central Nervous System involvement by CLL
  • Severe chronic obstructive lung disease with hypoxemia
  • Severe diabetes mellitus
  • Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection)
  • Active or non-active autoimmune hemolytic anemia (AIHA) (isolated positive DAT is not an exclusion criterion, but reticulocytes/haptoglobin levels must be in lab normal ranges) or idiopathic thrombocytopenic purpura (ITP), requiring steroid therapy with > 20 mg daily of prednisone dose or equivalent.
  • Any prior history of Richter transformation or DLBCL
  • Any evidence or suspicion of Richter transformation or DLBCL during screening
  • Active malignancy other than the one treated in this trial. Prior history of malignancies unless the participant has been free of the disease for ≥ 2 years.

However, participants with the following history /conditions that have been treated with a curative intent are allowed:

  1. Non-invasive basal cell or epidermoid carcinoma (non melanoma)
  2. In situ carcinoma of the cervix
  3. In situ carcinoma of the breast
  4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system

  5. Woman with adjuvant endocrine therapy (I.e., hormonotherapy) after breast cancer treatment can be enrolled if hormonotherapy was started for ≥ 2 years

    • History of stroke or intracranial hemorrhage within 6 months prior to ICF signature.
    • Major surgery 28 days before the ICF signature
    • History or known bleeding disorders (e.g hemophilia or von Willebrand disease)
    • Active Hepatitis C Virus (HCV) infection (RNA PCR-positive). Participants who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable
    • Active Hepatitis B Virus (HBV) infection (DNA PCR-positive). Participants with evidence of prior HBV infection but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy during the entire treatment with active monitoring of viral load in the blood
    • Patient with a positive HIV test before enrollment are eligible provided that they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.Known or suspected hypersensitivity or anaphylaxis to trial intervention including active substance or to any of the excipients.
    • Requires or receiving anticoagulation with warfarin or dual antiplatelets therapy equivalent vitamin K antagonists (other anticoagulants allowed: novel oral anticoagulant alone, aspirin alone, heparin alone).
    • Requires treatment with a strong/moderate cytochrome CYP3A4 inhibitor/inducer.
    • Participation in another clinical study who would compromise the participation to the current study.
    • Vaccinated with live, attenuated vaccines within 6 months of ICF
    • Use of any standard or experimental anti-cancer drug therapy within 28 days before the start (Day 1) of study treatment
    • Corticosteroid use > 20 mg per day within 1 week before the first dose of trial intervention, except as indicated for other medical conditions, such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of trial intervention or contrast.
    • Any significant medical conditions, or laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical trial or affect interpretation of trial outcomes (according to the investigator's decision)
    • Any uncontrolled and/or active significant infection (eg, bacterial, viral, or fungal; including participants with positive cytomegalovirus PCR).
    • Participant deprived of their liberty by a judicial or administrative decision
    • Participant hospitalized without consent
    • Adult participant under legal protection

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Zanubrutinib
Participants will receive oral zanubrutinib followed by a predefined dose reduction strategy. Treatment will continue until disease progression, permanent treatment discontinuation, withdrawal of consent, loss to follow-up, or the end of study participation.
의약품: Zanubrutinib
Zanubrutinib is a Bruton tyrosine kinase (BTK) inhibitor administered orally.
다른 이름들:
  • 브루킨사

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-Free Survival (PFS)
기간: 30 months and 5 years
The primary endpoint is the Progression-Free Survival (PFS).
30 months and 5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Permanent Treatment Discontinuation (PTD) Rate
기간: 18 months
The key secondary endpoint is the rate of permanent treatment discontinuation (PTD).
18 months
Overall Survival (OS)
기간: At 30 months and at 5 years
The secondary efficacy endpoint 1 is the Overall Survival (OS).
At 30 months and at 5 years
Time to Next Anti-Leukemia Treatment
기간: At 30 months and at 5 years
The secondary efficacy endpoint 2 is the Time to Next Anti-Leukemia Treatment (TTNLT).
At 30 months and at 5 years
Overall Response Rate
기간: At 18 months and at 30 months
The secondary efficacy endpoints 3 and 4 are Overall Response Rate (ORR) at 18 months and at 30 months, respectively.
At 18 months and at 30 months
Change From Baseline in Geriatric Assessment Scores
기간: at baseline, at 18 months, at 30 months and at 42 months
Geriatric condition will be evaluated using minimal nurse-delivered scales recommended by the SIOG.
at baseline, at 18 months, at 30 months and at 42 months
Health-Related Quality of Life
기간: At baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Health-Related Quality of Life as assessed by Questionnaire
At baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Frailty Assessment Score
기간: At baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Frailty status will be assessed using a validated frailty scale.
At baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Patient-Reported Treatment Side Effect Burden
기간: Baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Treatment side effect burden will be assessed using a patient-reported questionnaire.
Baseline, every 3 months for the first 2 years, and every 6 months thereafter for 3 years.
Incidence and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
기간: From first dose of study treatment until the end of study participation (up to 5 years).
Safety will be assessed by the incidence, severity, and seriousness of adverse events, including serious adverse events and adverse events of special interest.
From first dose of study treatment until the end of study participation (up to 5 years).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Lymphoma Academic Research Organisation

협력자

Lymphoma Study Association
BeOne Medicines

수사관

  • 수석 연구원: Loïc YSEBAERT, Professor, IUCT Oncopole
  • 수석 연구원: Emmanuelle FERRANT, Doctor, Hospices Civils de Lyon

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 1일

기본 완료 (추정된)

2029년 4월 1일

연구 완료 (추정된)

2032년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 28일

QC 기준을 충족하는 최초 제출

2026년 7월 28일

처음 게시됨 (실제)

2026년 7월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ZEN-CLL
  • 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-525080-32-00 (씨티스)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다