Lymphoma Clinical Trials
A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Intolerant of Prior Treatment with Ibrutinib
Lauren Downing, BS, CCRP
Treatment Agent: Zanubrutinib
Synopsis: You are being asked to take part in this study because you have been diagnosed with a cancer called Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
The purpose of this study is to study the safety and efficacy of the study drug zanubrutinib (also known as BGB-3111) in Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) patients who discontinued prior ibrutinib treatment due to toxicities.
Zanubrutinib is an experimental drug. This means that it has not been approved for use by the regulatory agencies in any country, but it can be used in research studies such as this one. As of September 2018, zanubrutinib has been given to approximately 1200 participants who are taking or have taken part in research studies with zanubrutinib as a single drug or in combination with another anticancer drug.
Zanubrutinib blocks a protein called Bruton Tyrosine Kinase (BTK). BTK helps CLL/SLL cells live and grow. By blocking BTK, zanubrutinib is capable of stopping or slowing down the growth and activity of CLL/SLL cells, which can lead to improvement in the symptoms associated with CLL/SLL. However, not all patients will improve to the same degree, and some patients might not improve at all.
- Age 18 years or older receiving treatment with ibrutinib for a minimum of 4 weeks prior to enrollment
- CLL or SLL that meets diagnostic criteria and requires treatment by 2008 iwCLL criteria prior to initiation of ibrutinib.
- Intolerant to ibrutinib
- Ibrutinib-related toxicities must have resolve to Grade ≤ 1 or baseline prior to initiating treatment with zanubrutinib
- ECOG performance status ≤ 2
- Adequate bone marrow function
- Adequate renal and hepatic function
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Intervening anticancer therapy after discontinuation of ibrutinib and prior to initiation of zanubrutinib
- Clinically significant cardiovascular disease
- History of ischemic stroke within 180 days before first dose of zanubrutinib
- History of CNS hemorrhage
- Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
- History of inherited or acquired hemorrhagic coagulopathy
- Unable to swallow capsules, or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Known CNS involvement by leukemia or lymphoma
- Documented progressive disease (PD) during ibrutinib treatment up to the time of enrollment
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- Known infection with HIV or active viral hepatitis B or C infection
- History of opportunistic infection while on ibrutinib
- Major surgery within 4 weeks of the first dose of study drug
- Pregnant or lactating women
- Ongoing alcohol or drug addiction
- Prior exposure to zanubrutinib or hypersensitivity to zanubrutinib formulation excipients
- Concurrent participation in another therapeutic clinical trial
Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices
Lauren Downing, BS, CCRP
Treatment Agent: N/A
Synopsis: The purpose of this study is to gather data on patients like you, who have been diagnosed with classical Hodgkin Lymphoma (cHL). The study aims to collect information on how treatment for cHL is rendered, as well as assess the outcome of those treatment options.
- Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
- Patients who are treatment-naïve, or are within ± 2 weeks beginning any line of therapy at time of enrollment
- Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy-based regimens.
- Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
- Patients must have available medical records for the date of diagnosis of cHL and available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anti-cancer therapy received.
- Patients must consent for use of their FFPE tissue blocks for exploratory analyses
- Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
- Patients with unknown date of diagnosis of cHL
- Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
- Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
- Patients participating in a clinical study that does not allow enrollment into a non-interventional study
- Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.
Other protocol defined inclusion/exclusion criteria could apply