Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (CLL17)

  • STATUS
    Recruiting
  • End date
    Mar 24, 2027
  • participants needed
    897
  • sponsor
    German CLL Study Group
Updated on 24 March 2022
platelet count
gilbert's syndrome
cytopenia
thrombocytopenia
venetoclax
neutrophil count
ibrutinib
obinutuzumab

Summary

The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL.

Details
Condition Chronic Lymphoid Leukemia
Treatment Ibrutinib, Obinutuzumab, venetoclax
Clinical Study IdentifierNCT04608318
SponsorGerman CLL Study Group
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documented CLL requiring treatment according to iwCLL criteria
Age at least 18 years
Life expectancy ≥ 6 months
Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows, unless cytopenia is due to CLL
Absolute neutrophil count ≥ 1.0 × 109/L
Platelet counts ≥ 30 × 109/L; in cases of thrombocytopenia clearly due to CLL (per the discretion of the investigator), platelet count should be ≥ 10 × 109/L
Total haemoglobin ≥ 9 g/dL (without transfusion support, unless anaemia is due to CLL)
GFR >30ml/min directly measured with 24hr urine collection, calculated according to
the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x
For patients with creatinine values within the normal range the calculation of the clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 30 ml/min may be eligible if a repeat estimate after adequate hydration is > 30 ml/min
bodyweight)/ (72 x creatinine), for women x 0, 85) or an equally accurate
method
Negative serological testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle), negative testing for hepatitis C RNA within 6 weeks prior to registration for study screening (i.e. PCR only required when serology was positive)
Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2
Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the
institutional ULN value, unless directly attributable to the patient's CLL or
to Gilbert's Syndrome

Exclusion Criteria

Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted)
Transformation of CLL (Richter transformation). When Richter transformation is suspected, PET-CT and/or biopsy should be performed to rule out transformation
Patients with a history of PML
Malignancies other than CLL currently requiring systemic therapies, not being treated with curative intent before (unless the malignant disease is in a stable remission due to the discretion of the treating physician or showing signs of progression after curative treatment
Uncontrolled or active infection
Patients with known infection with human immunodeficiency virus (HIV)
Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/ inducers (incl. up to 7 days prior to study treatment start)
Anticoagulant therapy with warfarin or phenprocoumon, (alternative anticoagulation is allowed (e.g. DOACs), but patients must be properly informed about the potential risk of bleeding under treatment with ibrutinib)
An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients' safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract)
History of stroke or intracranial hemorrhage within 6 months prior to registration for study screening
Known bleeding disorders
Child B / C liver cirrhosis
Use of investigational agents which might interfere with the study drug within 28 days prior to registration for study screening
Vaccination with live vaccines 28 days prior to registration for study screening
Major surgery less than 30 days before start of study treatment
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, known sensitivity or allergy to murine products
Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial
Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of study treatment; further pregnancy testing will be performed monthly)
Fertile men or women of childbearing potential unless
willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 18 months after the end of study treatment
Legal incapacity
Prisoners or subjects who are institutionalized by regulatory or court order
Persons who are in dependence to the sponsor or an investigator
surgically sterile or ≥ 2 years after the onset of menopause
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