Intensified Post Remission Therapy Containing PEG-Asparaginase
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|ClinicalTrials.gov Identifier: NCT00184041|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs that are given in different combinations in several steps. Each step of treatment is called a cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL and which are given in multiple treatment cycles over several months. All the chemotherapy drugs that are used in this study have been approved by the Food and Drug Administration (FDA).
One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It is given together with the other drugs throughout the different cycles of treatment. This drug can be derived from several sources. The standard source is called E. coli Asparaginase, which is associated with a risk of allergic reactions. This drug stays in the body for a very short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of treatment.
In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also called Oncospar), which remains in the body for about two weeks, therefore, it can be given only once in a cycle of treatment and still maintains high blood levels of the drug. PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience with the drug has been in children with ALL. In children it was found to be as safe as the standard form of Asparaginase and with less allergic reaction. It was also found to have the same effectiveness on ALL. The experience with this drug in adults has been more limited.
The purpose of the study is to find out what side effects occur in adults when PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the response to treatment of ALL. Another purpose is to find out if the allergic reactions are reduced with PEG-Asparaginase. In children there is some early information that PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop antibodies against the drug.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Of Newly Diagnosed Adult Acute Lymphoblastic Leukemia With Intensified Post Remission Therapy Containing PEG-Asparaginase.|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
U.S. FDA Resources
Experimental: Intensified Post-Remission: MTX/LV/PEG-Asparaginase
Daunorubicin 60 mg/m2 iv on days 1, 2, 3 Vincristine 1.4 mg/m2 iv on days 1, 8, 15, 22 Peg-Asparaginase 2000 U/m2 iv on day 15 Prednisone 60 mg/m2 mg po on days 1-28 MTX 12 mg IT on days 8 & 15
Drug: Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine
Induction I/II, consolidation I/II/III/IV and Maintenance
- Assessment of pt developing anti-asparaginase antibody [ Time Frame: assessed 3 times ]
- Response [ Time Frame: By Bone Marrow assessment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184041
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90032|
|Principal Investigator:||Dan Douer, MD||University of Southern California|