Methods for providing a system of care for a high-dose oxazaphosphorine drug regimen
First Claim
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1. A method of providing a system of care with a high-dose oxazaphosphorine drug regimen to treat or delay the onset of transplant rejection, comprising, carrying out the following steps prior to administration of the high-dose oxazaphosphorine drug regimen:
- a. registering a subject and generating a unique identifier for the subject in a non-transitory computerized storage medium;
b. providing counseling to the subject regarding the risks associated with the administration of the high-dose oxazaphosphorine drug regimen, and obtaining the subject'"'"'s informed consent for participation in the regimen;
c. registering one or more of the following items in the storage medium;
1) results of two independent pregnancy tests from the subject in the case of a female subject,2) a measure of the level of aldehyde dehydrogenase (ALDH) enzyme in the subject'"'"'s peripheral lymphocytes,3) a measure of the level of ALDH enzyme in the subject'"'"'s hematogenous stem cells,4) a measure of the white blood cell (WBC) count of the subject prior to and after the high-dose oxazaphosphorine drug regimen,5) result of an assay for detecting the presence of one or more viruses in the subject;
6) a measure of the QT/QTc interval of the subject,7) a platelet count from the subject,8) a neutrophil count from the subject,9) a record of the subject meeting the qualifying inclusion criteria, or10) the absence of exclusion criteria, or a combination of any of the foregoing,d. registering in the storage medium all pharmaceuticals or other substances currently being administered to the subject, and confirming in the storage medium that none of the pharmaceuticals include contraindicated pharmaceuticals or substances;
e. computing an approval status code upon successful completion of steps a-d which corresponds to the subject'"'"'s identifier within the storage medium; and
f. transmitting to an administration facility authorization to administer the high-dose oxazaphosphorine drug regimen to the subject based on the approval status code, or transmitting to the drug manufacturer authorization to release the oxazaphosphorine of the high-dose oxazaphosphorine regimen to the administration facility based on the approval status code, causing the administration facility to administer the high-dose oxazaphosphorine drug regimen to the subject based on the approval status code, to treat or delay the onset of transplant rejection.
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Abstract
The present invention provides methods of treating subjects with an oxazaphosphorines, methods of identifying subjects that are suitable for oxazaphosphorine treatment, and systems for ensuring the safety and efficacy of a treatment that includes oxazaphosphorine administration.
66 Citations
32 Claims
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1. A method of providing a system of care with a high-dose oxazaphosphorine drug regimen to treat or delay the onset of transplant rejection, comprising, carrying out the following steps prior to administration of the high-dose oxazaphosphorine drug regimen:
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a. registering a subject and generating a unique identifier for the subject in a non-transitory computerized storage medium; b. providing counseling to the subject regarding the risks associated with the administration of the high-dose oxazaphosphorine drug regimen, and obtaining the subject'"'"'s informed consent for participation in the regimen; c. registering one or more of the following items in the storage medium; 1) results of two independent pregnancy tests from the subject in the case of a female subject, 2) a measure of the level of aldehyde dehydrogenase (ALDH) enzyme in the subject'"'"'s peripheral lymphocytes, 3) a measure of the level of ALDH enzyme in the subject'"'"'s hematogenous stem cells, 4) a measure of the white blood cell (WBC) count of the subject prior to and after the high-dose oxazaphosphorine drug regimen, 5) result of an assay for detecting the presence of one or more viruses in the subject; 6) a measure of the QT/QTc interval of the subject, 7) a platelet count from the subject, 8) a neutrophil count from the subject, 9) a record of the subject meeting the qualifying inclusion criteria, or 10) the absence of exclusion criteria, or a combination of any of the foregoing, d. registering in the storage medium all pharmaceuticals or other substances currently being administered to the subject, and confirming in the storage medium that none of the pharmaceuticals include contraindicated pharmaceuticals or substances; e. computing an approval status code upon successful completion of steps a-d which corresponds to the subject'"'"'s identifier within the storage medium; and f. transmitting to an administration facility authorization to administer the high-dose oxazaphosphorine drug regimen to the subject based on the approval status code, or transmitting to the drug manufacturer authorization to release the oxazaphosphorine of the high-dose oxazaphosphorine regimen to the administration facility based on the approval status code, causing the administration facility to administer the high-dose oxazaphosphorine drug regimen to the subject based on the approval status code, to treat or delay the onset of transplant rejection. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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13. The method of 1, wherein the authorization of (f) is selected from at least one of the following:
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1) a telephonic facsimile, paper, or Internet transmission of the subject'"'"'s unique identifier, 2) a telephonic facsimile, paper, or Internet transmission of the subject'"'"'s unique identifier in combination with an approval code for dispensing the oxazaphosphorine drug to the subject, 3) at least one dose of the oxazaphosphorine drug in a container affixed or otherwise associated with the subject'"'"'s unique identifying information, or any combination thereof.
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Specification