Clolar Profiles

Clolar was studied in 49 children with acute lymphoblastic leukemia (ALL) who had failed at least 2 prior treatments. The profiles below show how some of those patients responded.

Patient 1 profile

This patient is an 11-year-old Caucasian girl diagnosed with ALL in June 1996 when she was 2 years old.

At the time she was diagnosed, her doctors prescribed a round of chemotherapy, which caused the cancer to go into remission. Unfortunately, about 4 years later, the cancer came back (relapsed). She got another round of chemotherapy and went into remission again. Four years after that, however, the cancer came back again.

This time, the doctors gave her two cycles of Clolar. With Clolar, the cancer went into remission again. She had side effects that included allergic reaction, influenza A infection, and two events of low white blood cell counts with fever.

She was able to receive a cord blood transplant, and as of her last follow-up visit in March 2005, she was still in remission.

Patient 2 profile

This patient is a 12-year-old African-American boy diagnosed with pre-B cell ALL in September 2001 when he was 9 years old.

At the time he was diagnosed, his doctors prescribed a round of chemotherapy, which caused the cancer to go into remission. Unfortunately, the cancer came back about 3 years later. He received another round of chemotherapy but this time the cancer did not respond to the treatment it became refractory. Doctors tried 4 additional rounds of chemotherapy to try to get the cancer to go into remission, but it did not.

Then the boy was enrolled in the Clolar study and received 2 cycles of Clolar, which caused the cancer to go into remission. He had side effects that included two events of low white blood cell counts with fever. He received a cord blood transplant, but unfortunately passed away due to complications from the transplant.

A chance to respond

It is important to remember that not every patient will respond with Clolar. Your healthcare team is your best resource for helping prepare you for what to expect from treatment with Clolar.

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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.