Clinical Studies

Before it was approved by the FDA in December 2004, Clolar was tested in clinical studies. One of these studies tested Clolar in 49 children (ages 1 to 21 years old) who had acute lymphoblastic leukemia (ALL). All of these children had been previously treated with at least two other therapies that did not work to fight the cancer. Some of them (about 31%) had already had at least one prior transplant to treat the cancer. Learn more about this study in the section below. If you are a healthcare professional, you can read about this in the Study Data section.

What have studies with Clolar shown?

In the Clolar study, all 49 patients (29 boys and 20 girls) received Clolar. They were given the medication as an intravenous (IV) infusion over 2 hours for 5 consecutive days. They received additional cycles of Clolar every 2 to 6 weeks, depending on how their bodies responded.

After treatment with Clolar, 10 of the 49 patients went into remission. An additional 5 patients had a partial response to the treatment. Of those 15 patients who responded to treatment with Clolar, 6 of them were able to have a bone marrow transplant so that duration of remission could not be determined. The study, however, was not designed to test the ability of Clolar to get a patient to transplant.

A total of 9 patients responded to treatment and did not have a transplant. The length of time they stayed in remission during the time they were monitored in the study is in the table below.

Amount of time patients in the study stayed in remission as of last follow-up

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How Clolar is Used

Clolar is a type of medication to treat children, ages 1 to 21 with a type of leukemia called relapsed or refractory acute lymphoblastic leukemia (ALL), after at least 2 other treatment attempts have failed. Clolar can reduce the number of leukemia cells in the blood. At this time we do not know if Clolar will help a child with ALL live longer or cure him or her of the cancer.

Important Safety Information for Patients

Serious side effects

Clolar can cause serious side effects that include:

• Systemic inflammatory response syndrome (SIRS)/capillary leak syndrome (CLS). Signs include fast breathing, fast heartbeat, low blood pressure, and difficulty breathing. These signs should be reported to the physician right away, as SIRS and CLS can be life-threatening if not treated right way. If your child experiences clinically significant signs of SIRS or CLS, your physician should stop Clolar immediately and consider giving your child steroids, diuretics, and albumin. When your child has stabilized, Clolar can be continued, usually at a lower dose.
• Bone marrow suppression and infection. Clolar can stop your child’s bone marrow from making enough red blood cells, white blood cells, and platelets. Serious side effects can result from this, and include severe infection (sepsis), bleeding, and anemia.
• Effects on pregnancy and breastfeeding. Females should not become pregnant or breastfeed during treatment with Clolar because Clolar may harm the baby.

Other side effects

The most common side effects with Clolar are stomach problems (including vomiting, diarrhea, and nausea), and effects on blood cells (including low red and white blood cells count, low platelet count, fever, and infection). A fast heartbeat has been noted in some patients taking Clolar. Clolar can also affect the liver and kidneys. For these reasons, your child’s healthcare professional will do blood tests to monitor his or her blood cells, kidney function, and liver function.

Treatment with Clolar quickly reduces the number of leukemia cells in your child’s blood. For this reason, your doctor should monitor your child for signs and symptoms of tumor lysis syndrome (TLS), as well as signs and symptoms of cytokine release, which can develop into SIRS, CLS, and organ problems. Your doctor is encouraged to give continuous IV fluids throughout the five days of Clolar treatment to reduce certain side effects. Your doctor may also prescribe allopurinol to reduce the build-up of uric acid that occurs with TLS. Your doctor should stop the Clolar treatment if your child develops low blood pressure for any reason during the five days of treatment.

Please speak with your healthcare professional if you have questions about Clolar. Also, please see full prescribing information.