Bone and Cancer
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Clinical Trials

Leukine (sargramostim)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved on November 24, 1995

Specific Treatments:


Therapeutic Areas

General Information

Leukine has been shown to increase white blood cells after autologous and allogeneic bone marrow transplantation as well as after peripheral blood progenitor cell (PBPC) transplantation.

Leukine, a white blood cell stimulant, is a yeast-derived granulocyte-macrophage colony stimulating factor. It was originally licensed by the FDA in March, 1991 for use following autologous bone marrow transplantation (BMT) and was licensed in December 1991 to prevent death following BMT engraftment delay or failure. It has subsequently been licensed in September of 1995, to prevent early death from infection following induction chemotherapy for older subjects suffering from acute myelogenous leukemia (AML).

Clinical Results

In a study of 196 subjects, Leukine given to mobilize PBPCs significantly increased the number of progenitor cells collected. When Leukine was given after transplantation with mobilized PBPCs, there was a further acceleration in white blood cell recovery. In addition, the number of platelet transfusions and red blood cell transfusions needed were decreased, subjects were discharged from the hospital earlier when compared to subjects not receiving Leukine.

Side Effects

Leukine therapy was generally well tolerated with mild side effects.

Additional Information

Progenitor cells are vital in helping patients recover after chemotherapy and radiotherapy--two treatments for a variety of cancers.

Bone marrow harvesting has been the procedure traditionally used to obtain progenitor cells from the bone marrow. These same progenitor cells are present in small quantities in the peripheral blood and can be collected from peripheral blood through a procedure called apheresis. By giving a growth factor, such as Leukine, before apheresis, the number of progenitor cells in peripheral blood can be enhanced and the number of progenitor cells in peripheral blood can be enhanced and the number of apheresis procedures can be decreased.

After a subject’s progenitor cells are collected by apheresis, the cells are stored and later reinjected after high-dose chemotherapy with or without total body irradiation, to help repopulate the bone marrow. Using this procedure, larger numbers of PBPCs are collected which leads to more rapid engraftment. Apheresis is less invasive than bone marrow harvesting and requires no anesthesia. Therefore, using PBPC to repopulate the marrow following high-dose chemotherapy and/or radiotherapy is replacing the use of bone marrow progenitor cells in many settings.

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