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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensified Post-Remission: MTX/LV/PEG-Asparaginase | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daunorubicin, Vincristine, Prednisone, Methotrexate, PEG-Asparaginase, 6-Mercaptopurine, Cytoxan, Cytosine Arabinoside, VM-26 and 6-Thioguanine | Drug | Induction I/II, consolidation I/II/III/IV and Maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pt developing anti-asparaginase antibody | assessed 3 times |
| Measure | Description | Time Frame |
|---|---|---|
| Response | By Bone Marrow assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Douer, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24516026 | Derived | Douer D, Aldoss I, Lunning MA, Burke PW, Ramezani L, Mark L, Vrona J, Park JH, Tallman MS, Avramis VI, Pullarkat V, Mohrbacher AM. Pharmacokinetics-based integration of multiple doses of intravenous pegaspargase in a pediatric regimen for adults with newly diagnosed acute lymphoblastic leukemia. J Clin Oncol. 2014 Mar 20;32(9):905-11. doi: 10.1200/JCO.2013.50.2708. Epub 2014 Feb 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 24, 2025 | |
| Reset | Nov 5, 2025 | |
| Release | Jun 5, 2026 | |
| Reset | Jul 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 24, 2025 | Nov 5, 2025 | |||
| Jun 5, 2026 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D008727 | Methotrexate |
| C042705 | pegaspargase |
| D015122 | Mercaptopurine |
| D003520 | Cyclophosphamide |
| D003561 | Cytarabine |
| D013713 | Teniposide |
| D013866 | Thioguanine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Jul 1, 2026 |
| Jul 2, 2026 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D005960 | Glucosides |