You must sign a consent form before any study procedures begin.
If you are a woman who can become pregnant, you must use reliable birth control methods during the study and for up to 12 months after your last dose of study medicine, whichever is longer. Birth control methods include not having sex, having your tubes tied, using certain hormonal methods like the Mirena device (a small device placed in the uterus that releases hormones) or Depo Provera injection (a shot that prevents pregnancy), using a copper device placed in the uterus, or your male partner having had a vasectomy (a procedure to prevent pregnancy). If using hormonal birth control, your male partner must also use condoms. You must not breastfeed during the study. You must have a negative pregnancy test before starting treatment. You may join the study if you are past menopause, meaning you are over 50 years old and have not had a period for at least 12 months after stopping hormone treatments, or if you are under 50 years old and have not had a period for 12 months with certain hormone levels in the normal range for menopause. You may also join if you have had surgery to remove your uterus, both ovaries, or both fallopian tubes.
You must be 18 years old or older when signing the consent form.
Your general health and ability to care for yourself must be rated as 0, 1, or 2 on a scale called ECOG performance status, which measures how well you can perform daily activities. Your health should not have gotten worse in the past 2 weeks.
You must have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma, which are types of blood cancer. Your disease must have come back, not responded to treatment, or caused intolerable side effects during or after previous treatment with a BTK inhibitor, which is a type of cancer medicine. The disease is considered not responding to treatment if it gets worse during treatment or within 6 months after it improved. The disease has relapsed if it comes back after at least 6 months of having a partial or better response. Your disease is considered not responding to BTK inhibitor if it stays stable after 6 months of standard treatment, or if it gets worse after at least 8 weeks of treatment, or if it progresses after responding for at least 6 months. You may join if you stopped BTK inhibitor due to side effects such as the same moderate or worse non-blood-related side effect lasting 7 days or more and happening twice or more, the same severe non-blood-related side effect lasting 7 days or more or happening twice or more, very severe non-blood-related side effects, the same severe blood-related side effect lasting 7 days or more and happening twice or more, severe low white blood cell count with infection or fever, severe low platelet count with significant bleeding, very severe blood-related side effects lasting 7 days or more or happening twice or more, or moderate or higher side effects that your doctor judged as high risk.
You must have been previously treated with a BCL-2 inhibitor, which is another type of cancer medicine, according to local practice in European countries.
Your expected survival must be at least 3 months.
Your doctor must determine that you need treatment based on specific criteria, including disease remaining after initial treatment, worsening of anemia (low red blood cells) or thrombocytopenia (low platelets), enlarged spleen measuring 6 centimeters or more below the left rib or growing or causing symptoms, large lymph nodes measuring 10 centimeters or more or growing or causing symptoms, rapidly increasing white blood cell count rising 50 percent or more over 2 months or doubling in less than 6 months, cancer spread to organs like skin, kidney, lung, or spine causing symptoms, immune-related anemia or thrombocytopenia not responding well to steroids, or disease-related symptoms such as unintentional weight loss of 10 percent or more in 6 months, significant tiredness preventing usual activities, fevers of 100.5 degrees Fahrenheit or 38 degrees Celsius for 2 weeks or more without infection, or night sweats for 1 month or more without infection.
If you have small lymphocytic lymphoma, you must have at least one measurable tumor, meaning a lymph node larger than 1.5 centimeters or a tumor outside lymph nodes larger than 1.0 centimeters.
Your bone marrow and organs must function adequately. You must not have received blood transfusions or growth factors in the 7 days before joining. Your absolute neutrophil count (a type of white blood cell) must be at least 0.75 multiplied by 10 to the power of 9 per liter. Your platelet count (cells that help blood clot) must be at least 50 multiplied by 10 to the power of 9 per liter, or at least 75 if you will receive bendamustine and rituximab treatment. Your blood clotting times must be no more than 1.5 times the upper normal limit. Your total bilirubin (a substance from broken down red blood cells) must be no more than 1.5 times the upper normal limit, or no more than 3 times if you have Gilbert’s Syndrome (a harmless liver condition) or cancer in your liver. Your liver enzymes called ALT and AST must be no more than 2.5 times the upper normal limit, or no more than 3 times if you have cancer in your liver. Your creatinine clearance (a measure of kidney function) must be at least 30 milliliters per minute. Your left ventricular ejection fraction (a measure of how well your heart pumps blood) must be at least 50 percent as measured by echocardiography, which is an ultrasound test of your heart.
You must be able to follow study requirements for taking the study medicine and attending follow-up visits.
If you are a man whose female partner can become pregnant, you must use barrier contraception like condoms during the study and for up to 12 months after your last dose of study medicine, whichever is longer. You must also avoid donating sperm during the study and for up to 12 months after your last dose, whichever is longer. If you wish to father children, you should consider freezing sperm samples before starting treatment.
Italy 
Poland 
