Lymphoma MSK 15-236 (CRONOS 3)

Sponsor: Memorial Sloan Kettering Cancer Center

Number: MSK 15-236

A phase III study of Copanlisib and Rituximab in patients with relapsed indolent B-cell Non-Hodgkin’s Lymphoma (iNHL). This type of cancer is a cancer of the body’s immune system. The prognosis is good for patients in the early stages and the survival is as long as 20 years. Once the disease advances to late stages it is usually not curable. Indolent NHL are often treated with immunotherapy, radiation and chemotherapy. If the disease returns it can usually be retreated successfully as long as it remains low grade. 

The study is designed to evaluate the effectiveness of a new investigational drug called Copanlisib. This drug works by blocking the enzyme Phospho-Inositol-3-Kinase (PI3K). This enzyme is important for the growth of tumor cells.

The use of Copanlisib will be in combination with an already approved iNHL medication called Rituximab.  The purpose of the study is to find out how effective using Copanlisib (investigational) and Rituximab (approved) are together.

Study participants will be divided into two random groups. The study is double-blind meaning both the participants and the investigators are unaware of what medication the participant is getting. All patients will get Rituximab. The participants randomly assigned (by chance) into the first group (Arm A) will receive Copanlisib. The participants randomly assigned to the second group (Arm B) will receive a placebo (inactive medication).

If there is a safety concern your doctor can find out which group you were assigned to. Your doctor will also be made aware of which group you were in once the study is completed.

Who is eligible:

• Patients must have Relapsed Indolent B-Cell Non-Hodgkin’s lymphoma. Patients must NOT have a diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia 
• Patients must be cancer treatment free for at least 12 months
• Patients must have an Ejection fraction of >45 %
• Patients must be over the age of 18
• Patients must be physically able to provide self-care
• Patients must have a life expectancy of > 3 months
• Patients must have a Hemoglobin A1c <8.5
• Certain other medical requirements must be met.  See your doctor to be evaluated for this study.

Available at Hartford Hospital only