Treating Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Copiktra

Written by Bonnie Bachenheimer, PharmD, BCPS
Medically Reviewed by Rachel Maynard, PharmD on October 01, 2025
8 min read

Copiktra (duvelisib) is a type of cancer treatment for certain people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are slow-growing cancers that affect a type of white blood cell in your body called lymphocytes. Lymphocytes are cells that help your body fight infections. CLL and SLL cause your body to make too many lymphocytes that do not work as they should. These abnormal cells crowd out healthy cells over time and can lead to symptoms.

Some people with CLL or SLL may not have any symptoms for many years. Others may have symptoms and may have the disease spread to their lymph nodes, liver, and spleen. Common symptoms include tiredness, infections, night sweats, loss of appetite, weight loss, fever or chills, and swelling of lymph nodes in your neck, armpits, stomach, or groin.

Treatment of CLL or SLL depends on how advanced it is. In the early stages if you have no symptoms, you may not need any treatment besides having regular health care provider visits to make sure your condition has not changed. If CLL or SLL have advanced, treatment may include chemotherapy, immunotherapy, targeted therapy, radiation, surgery, or other types of treatment.

There is no cure for CLL or SLL, but treatment can put the cancer into remission, where there are no signs of active disease. Recurrent or relapsed CLL or SLL is when you have had CLL or SLL that went into remission but has come back. Refractory CLL or SLL does not get better even after treatment.

Copiktra is an oral medicine that is approved to treat people with relapsed or refractory CLL or SLL who have had at least two other types of treatment that did not work or are no longer working.

The main ingredient in Copiktra is duvelisib, a type of medicine called a targeted therapy.  Copiktra is a kinase inhibitor. Kinases are enzymes (proteins) on a cell that help the cell grow and divide. Copiktra works by blocking specific proteins that help cancer cells grow. This helps slow down the growth of cancer cells and may cause them to die.

Copiktra is a capsule that is taken twice a day, with about 12 hours between each dose. You can take it with or without food. Do not open, crush, break, or chew the capsules. Swallow the capsules whole.

Your health care provider may choose to decrease your dose, pause, or stop Copiktra completely if you have side effects. 

Copiktra may interact with certain medicines. Your dose of Copiktra may need to be lowered if you are taking certain medicines with it, or you may need to avoid certain medicines while you are taking Copiktra. You should tell your health care provider about all of the medicines or supplements that you are taking. 

In a clinical study called DUO, 319 people took either Copiktra or ofatumumab (another cancer medicine). People in the study had CLL or SLL that had worsened during treatment or relapsed after being treated with at least one other therapy for CLL or SLL.

The main goal of the study was to look at progression-free survival – the amount of time people live with the cancer before it progresses or gets worse after starting a certain medicine. The study also looked at overall response rate, which is defined by how many people got a response from the medicine. Specifically, it measures how many people had a partial or a complete response. Partial response is a decrease in the amount of cancer in your body. Complete response is when there are no signs of cancer in your body. The study also looked at overall survival – the amount of time a person remains alive after starting treatment with a medicine.

The approval of Copiktra was based on an analysis of people in the study who had at least two prior therapies. These people had the greatest benefits versus risks compared to the overall group of people studied. This subset included 196 people. The results listed below are from this subset of people. The median age (midpoint age of all the people in the study) was 69, and most people in the study were men (59%). Most of the people (54%) had received three or more treatments for CLL or SLL before the study started.

People in the study took either Copiktra 25 mg capsules by mouth twice per day or ofatumumab intravenously (as an infusion into a vein). Copiktra was taken until the disease worsened or they had serious side effects. Ofatumumab was given as a dose of 300 mg, followed one week later with 2,000 mg once per week for seven doses, then followed four weeks later by 2,000 mg once every four weeks for four doses.

The median time people in the study took Copiktra was 13 months. Most (80%) took it for at least six months and about half (52%) took it for at least 12 months. The median time people took ofatumumab was five months.

The median progression-free survival (the time it took for half of the people in the study to have disease progression or die after starting the medicine) in people who had used at least two prior therapies was 16.4 months for Copiktra compared to 9.1 months for ofatumumab. This means that people taking Copiktra lived longer without progression compared to ofatumumab.

People in the Copiktra group had an overall response rate of 78% compared to 39% of people in the ofatumumab group. No one had a complete response in either group.

There was no difference in overall survival between Copiktra and ofatumumab.

Your results may differ from what was seen in clinical studies. 

You may not see changes right away. It may take weeks to months before your health care provider can tell if Copiktra is working for you. Your health care provider will regularly check how well Copiktra works for your cancer by looking at results of tests such as blood tests, CT scans, or biopsies.

Copiktra can cause serious side effects that can be life-threatening. Tell your health care provider right away if you have any of the side effects listed below. Although some of these side effects are common with Copiktra, they can sometimes be severe. The way side effects are managed will depend on how serious the side effect is. Your health care provider may also need to change your dose, pause your medicine, or even stop your medicine altogether if you have certain side effects.

Copiktra can cause low blood counts, including low white blood cells (neutropenia), low red blood cells (anemia), and low platelets (thrombocytopenia). Keep all appointments for blood work and tell your health care provider if you have any new or bothersome symptoms.

  • Neutropenia can cause severe infections that can cause death. You can help reduce your risk of getting an infection by washing your hands often and staying away from people who are sick or who have an infection, such as a cold or the flu. Your health care provider may prescribe medicine to help prevent infections. You should contact your health care provider right away if you get a fever, chills, or any other signs of an infection such as a sore throat or cough. They may prescribe you medicine to treat your infection or may adjust your dose of Copiktra or temporarily stop it.
  • Anemia can make you feel more tired than usual or have shortness of breath. Your health care provider may need to adjust your dose of Copiktra or use other therapies to manage your symptoms. 
  • Thrombocytopenia can cause you to bruise or bleed easier than normal. Things you can do to prevent this include using an electric shaver instead of a razor, using a soft bristled toothbrush to brush your teeth, and avoiding contact sports.

Copiktra may cause gastrointestinal (GI) side effects such as diarrhea or inflammation of your intestines. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. If you have diarrhea, your health care provider may recommend that you take antidiarrhea medicine and drink more fluids to avoid dehydration. If diarrhea medicine does not work or you have mucus or blood in your stool or severe stomach pain, tell your health care provider right away. You may need treatment with a steroid medicine.

Skin reactions are a common side effect of Copiktra. If you get a rash or other skin reactions, you should contact your health care provider right away. Depending on how severe the rash is, they may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a steroid medicine that is applied to the skin to treat your rash. 

Copiktra may cause inflammation of your lungs, which can be fatal. Tell your health care provider if you have a new or worsening cough or trouble breathing. Your health care provider may need to do tests to check your lungs and you may need to take a steroid medicine if your symptoms are not caused by an infection.

These are not all the possible side effects of Copiktra. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).

There are many other medicines that can increase or decrease the blood levels of Copiktra, which could increase your risk for side effects or make Copiktra not work as well. These medicines are called cytochrome CYP3A inducers and inhibitors. These medicines include rifampin, which is a medicine used to treat bacterial infections, and posaconazole, which is a medicine used to prevent fungal infections. Tell your health care provider about all the prescription and over-the-counter medicines and supplements you are taking. Your health care provider can tell you if you are taking a medicine or supplement that affects CYP3A.

There is a patient support program offered by the drugmaker called Secura Care that may help you afford Copiktra. Your health care provider can help you get started.  You can find out more at copiktra.com/patient-assistance or by calling 844-973-2872.