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New treatment option for Chronic Lymphocytic Leukemia
Official title Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
ClinicalTrials.gov ID: NCT06544785
What this study is testing
What is Zanubrutinib Oral Product?
Zanubrutinib Oral Product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as Zanubrutinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this phase II randomized open label study is to compare the rate of complete remission (CR) with undetectable minimal residual disease (uMRD) obtained with zanubrutinib in combination with obinutuzumab with two different schedules of administration of obinutuzumab (starting obinutuzumab at cycle 2 or 12 months) in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). There is scarce information about which is the most appropriate schedule of combining the BTKi and the anti-CD20 monoclonal antibody, and whether treatment can be safely stopped in those patients attaining deep responses (CR with uMRD) remains to be determined.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients with previously untreated CLL defined following IWCLL criteria (Hallek, 2018).
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol...
- Must have a documented diagnosis of CLL or SLL [IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2018)] meeting at least one of the...
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
You likely can't join if
- Prior treatment for CLL.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection. people who are hepatitis B core antibody...
- Estimated Glomerular Filtration Rate (Cockcroft-Gault Appendix C) ≤30 mL/min/1.73m2.
- Absolute neutrophil count (ANC) \< 1.0 X 109/L.
- Platelet count \< 75 X 109/L, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 109/L.
- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate...
See the full eligibility criteria
Who can join
- Adult patients with previously untreated CLL defined following IWCLL criteria (Hallek, 2018).
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form and must be able to adhere to the study visit schedule and other protocol requirements.
- Must have a documented diagnosis of CLL or SLL [IWCLL guidelines for diagnosis and treatment of CLL (Hallek, 2018)] meeting at least one of the following criteria:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
- Massive (i.e. ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- Massive nodes (i.e. ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or lymphocyte doubling time (LDT) of less than 6 months.
- A minimum of any one of the following disease-related symptoms: unintentional weight loss ≥ 10% within the previous 6 months, significant fatigue (i.e., ECOG PS 2 or worse; cannot work or unable to perform usual...
- Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids.
- Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine).
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
- Female patients of childbearing potential must practice highly effective methods of contraception initiated prior to first dose of study drug, for the duration of the study, and for ≥ 90 days after the last dose of...
- Combined (estrogen- and progestogen- containing) hormonal contraception associated with the inhibition of ovulation - Oral, intravaginal, or transdermal.
- Progestogen-only hormonal contraception associated with the inhibition of ovulation - Oral, injectable, implantable.
- An intrauterine device.
- Intrauterine hormone-releasing system.
- Bilateral tubal occlusion.
- Vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the woman of childbearing potential study participant and that the vasectomized partner has received medical assessment of...
- Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day prior to first dose of study drug, for the duration of the...
- Female people of childbearing potential must have a negative pregnancy test at screening. Females of child bearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence...
What rules you out
- Prior treatment for CLL.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection. people who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative could be...
- Estimated Glomerular Filtration Rate (Cockcroft-Gault Appendix C) ≤30 mL/min/1.73m2.
- Absolute neutrophil count (ANC) \< 1.0 X 109/L.
- Platelet count \< 75 X 109/L, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 109/L.
- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \>2.5 x upper limit of normal (ULN).
- Serum total bilirubin \> 1.5 x ULN, except in cases of Gilbert's syndrome.
- Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) \> 2x ULN.
- Active bleeding, history of bleeding diathesis (eg, haemophilia or von Willebrand disease).
- Unable to swallow capsules, or has disease significantly affecting gastrointestinal function that would limit absorption of oral medication.
- Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 3 months prior to enrollment. Exception: people with controlled, asymptomatic atrial fibrillation during...
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
- Systemic infection that has not resolved prior to initiating study treatment in spite of adequate anti-infective therapy.
- Pregnant or lactating females.
- Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.
- Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging.
- Prior history of malignancies, other than CLL, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Presence of autoimmune haemolytic anaemia or autoimmune thrombocytopenia.
- Major surgery within the last 28 days prior to registration.
- History of stroke or intracranial haemorrhage within 6 months prior to enrollment.
- Requires treatment with strong CYP3A4/5 Inhibitors.
- Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of zanubrutinib, or...
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Spain
- Barcelona, Spain
- Córdoba, Spain
- Las Palmas de Gran Canaria, Spain
- Madrid, Spain
- Marbella, Spain
- Málaga, Spain
- Oviedo, Spain
- Palma de Mallorca, Spain
- Pamplona, Spain
- Salamanca, Spain
- Santander, Spain
- Seville, Spain
- Valencia, Spain
- Vigo, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Spain; Barcelona, Spain; Córdoba, Spain; Las Palmas de Gran Canaria, Spain; Madrid, Spain; Marbella, Spain and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.