Useful Links

The links below will connect you to relevant medical societies and cancer organizations. Note that Genzyme Corporation does not review or control the content on non-Genzyme websites and providing these links does not constitute an endorsement by Genzyme of the site's content.

American Association for Cancer Research (AACR)

A source of information about advances in the causes, diagnosis, treatment and prevention of cancer.
http://www.aacr.org/

American Cancer Society

A nationwide, community- based voluntary health organization committed to fighting cancer through balanced programs of research, education, patient service, advocacy, and rehabilitation.
http://www.cancer.org/

American Society of Clinical Oncology

A professional organization representing physicians who treat people with cancer.
http://www.asco.org/

American Society of Hematology (ASH)

A professional society concerned with the causes and treatment of blood disorders.
http://www.hematology.org/

American Society of Pediatric Hematology/Oncology (ASPHO)

A professional society of pediatric hematologists/oncologists, who study and treat childhood cancer and blood diseases.
http://www.aspho.org/

Association of Pediatric Oncology Nurses (APON)

A professional organization for registered nurses caring for children and adolescents with cancer and blood disorders and their families.
http://www.apon.org/

CenterWatch

An organization that provides information services used by patients, pharmaceutical, biotechnology and medical device companies, CROs and research centers involved in clinical research around the world.
http://www.centerwatch.org/

Childhood Leukemia Foundation

A national non-profit organization that offers a wide range of services at no charge to the child and family and is dedicated to enhancing the quality of life of children with cancer.
http://www.clf4kids.org/

ClinicalTrials.gov

A website that provides regularly updated information about federally and privately supported clinical research in human volunteers.
http://www.clinicaltrials.gov/

CureSearch

CureSearch unites the Children's Oncology Group (COG) and the National Childhood Cancer Foundation (NCCF) through a shared mission to cure and prevent childhood and adolescent cancer through scientific discovery and compassionate care.
http://www.curesearch.org/

Genzyme Oncology

Genzyme Oncology is focused on developing and commercializing novel treatments for cancer patients through promising internal research and active external collaborations.
http://www.genzymeoncology.com

Ped-Onc Resource Center

Resources and information for parents of children with cancer, by parents of children with cancer.
http://www.acor.org/ped-onc/cfissues/maillist.html

The Leukemia and Lymphoma Society

A voluntary health organization dedicated to funding blood cancer research, education and patient services.
http://www.leukemia-lymphoma.org/

National Cancer Institute

A component of the National Institutes of Health (NIH), the National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, treatment, and care of cancer.
http://www.cancer.gov/

National Children’s Leukemia Foundation

A non-profit organization in the fight against leukemia and cancer for children and adults.
http://www.leukemiafoundation.org/

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Indication

Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Important Safety Considerations

Clolar should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Suppression of bone marrow function, which is usually reversible and dose dependent, should be anticipated and is likely to increase the risk of infection, including severe sepsis. Administration of Clolar results in a rapid reduction in peripheral leukemia cells. Patients should be evaluated and monitored for signs and symptoms of tumor lysis syndrome and cytokine release (e.g., tachypnea, tachycardia, hypotension, pulmonary edema) that could develop into systemic inflammatory response syndrome (SIRS)/capillary leak syndrome, and organ dysfunction. Clolar should be discontinued immediately in the event of clinically significant signs or symptoms of SIRS or capillary leak syndrome, either of which can be fatal, and use of steroids, diuretics, and albumin considered.

The most common adverse effects after Clolar treatment, regardless of causality, were gastrointestinal tract symptoms, including vomiting (grade 3: 8%; grade 4: 1%), nausea (grade 3: 15%; grade 4: 1%), and diarrhea (grade 3: 10%); hematologic effects, including anemia (grade 3: 70%; grade 4: 18%), leukopenia (grade 4: 99%), thrombocytopenia (grade 3: 36%; grade 4: 64%), neutropenia (grade 3: 3%; grade 4: 7%), and febrile neutropenia (grade 3: 53%; grade 4: 3%); and infection (grade 3: 56%; grade 4: 18%).

Hepato-biliary toxicities were frequently observed in pediatric patients during treatment with Clolar. The most frequently reported cardiac disorder was tachycardia (34%), which was, however, already present in 27.4% of patients at study entry. Left ventricular systolic dysfunction was also noted. Since Clolar is excreted primarily by the kidneys, drugs with known renal toxicity should be avoided during the 5 days of Clolar administration. In addition, since the liver is a known target organ for Clolar toxicity, concomitant use of medications known to induce hepatic toxicity should also be avoided.

Severe bone marrow suppression, including neutropenia, anemia, and thrombocytopenia, have been observed in patients treated with Clolar. Because of the pre-existing immunocompromised condition of these patients and prolonged neutropenia that can result from treatment with Clolar, patients are at increased risk for severe opportunistic infections.

Pericardial effusion was a frequent finding in these patients on post-treatment studies. Careful hematologic monitoring during therapy is important. Hepatic and renal function should be assessed prior to and during treatment with Clolar, as the liver is a target organ for Clolar toxicity and the kidneys are the predominant mode of Clolar excretion.

Patients receiving Clolar may experience vomiting and diarrhea; they should therefore be advised regarding appropriate measures to avoid dehydration. Clolar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant and avoid breastfeeding while receiving treatment with Clolar.

For more information, please consult the Full Prescribing Information (PDF).