RecruitingPhase 2

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

United States230 participantsStarted 2019-02-22

Plain-language summary

The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. CLL or SLL
✓. MCL
✓. prior local radiation for symptomatic disease is permitted
✓. Short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication (must be ≤ 14 days and \< 100 mg/day prednisone or ≤ 20 mg/day dexamethasone). Steroids must be discontinued prior to study treatment. Inhaled steroids for asthma, topical steroids, and replacement/Stress corticosteroids are permitted. Low-dose steroids for ITP are also permitted up to the equivalent prednisone 20mg/daily at time of eligibility review.
✓. Absolute neutrophil count (ANC) ≥1.0 x 109/L unless neutropenia is clearly due to disease under study (per investigator discretion)
✓. Platelet count ≥ 75,000/mm3 - OR - Platelet count ≥ 20,000/mm3 if thrombocytopenia is clearly due to disease under study (per investigator discretion)
✓. Hemoglobin ≥9.0 g/dL unless anemia is clearly due to marrow involvement due to disease under study (per investigator discretion)
✓. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion criteria

✕. Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T cell count of ≥ 200 cells/microliter

What they're measuring

establish the rate of minimum residual disease (MRD) undetectable response

Timeframe: 1 year

Trial details

NCT IDNCT03824483

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Andrew Zelenetz, MD, PhD

212-639-2656 zeleneta@mskcc.org

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia (CLL) trials