Claims for Patent: 7,815,921

Summary for Patent: 7,815,921

Title:	Cytocapacity test for the prediction of the hematopoietic recovery, neutropenic fever, and antimicrobial treatment following high-dose cytotoxic chemotherapy
Abstract:	The present invention relates to a method for determining the hematopoietic cytocapacity of a subject comprising the steps of: (a) determining the amount of leukocytes present in a blood sample obtained from a subject, wherein said subject has been subjected to administration of a single dose of G-CSF and has been maintained for a time sufficient to allow mobilization or release of the leukocytes from hematopoietic production and storage tissues and sites of margination into the blood; and (b) determining the hematopoietic cytocapacity by assessing the amount of leukocytes determined in step (a) with the amount of leukocytes which have been mobilized or released in a control subject wherein said control subject is selected from the group consisting of subjects having (i) a high risk for a disease, disorder or complication associated with high-dose cytotoxic chemotherapy and/or hematopoietic cell transplantation, (ii) an intermediate risk for a disease, disorder or complication associated with high-dose cytotoxic chemotherapy and/or hematopoietic cell transplantation or (iii) a low risk for a disease, disorder or complication associated with high-dose cytotoxic chemotherapy and/or hematopoietic cell transplantation.
Inventor(s):	Straka; Christian (Pocking, DE)
Assignee:	Ludwid Maximilians Universitat (Munich, DE)
Application Number:	10/508,509
Patent Claims:	1. A method for predicting the risk of diseases, disorders or complications associated with cytotoxic therapy and/or hematopoietic cell transplantation in a subject comprising the step of: (a) identifying a subject with multiple myeloma or lymphoma that has received cytotoxic therapy comprising chemotherapy; (b) administering to the subject a single dose of G-CSF sufficient to allow mobilization or release of the leukocytes from hematopoietic production and storage tissue and sites of migration into the blood of the subject; and (c) determining whether the subject has high, medium or low hematopoietic cytocapacity; wherein a subject with a high hematopoietic cytocapacity indicates a reduced risk of disease, disorder, or complications associated with cytotoxic therapy and/or hematopoietic cell transplantation relative to a subject with low or medium hematopoietic cytocapacity, wherein the disease, disorder, or complications are selected from fever greater than 38.degree. C., severity and duration of neutropenia, duration of leucopenia, infection, duration of i.v. antibiotic treatment, time for platelet recovery, or time for neutrophil recovery. 2. A method for selecting a suitable antimicrobial prophylaxis or therapy for a subject, wherein said method comprises the steps of the method of claim 1 and the further step (d) of selecting a suitable antimicrobial prophylaxis or therapy for said subject based on the result obtained in step (c). 3. A method according to claim 2, wherein said prophylaxis or therapy is a prophylaxis or therapy for the treatment, prevention or amelioration of an infection. 4. A method according to claim 3, wherein said infection is selected from the group of fungal, viral, protozoal, parasitical and bacterial infections. 5. A method according to claim 3, wherein said infection is selected from the group consisting of pneumonia, invasive fungal infection, enterocolitis, soft-tissue infection, and sepsis. 6. A method for selecting a suitable prophylaxis or therapy for neutropenic fever for a subject, wherein said method comprises the steps of the method of claim 1 and the further step (d) selecting a suitable prophylaxis or therapy for neutropenic fever for said subject based on the result obtained in step (c). 7. A method for selecting a suitable amount of hematopoietic stem cells to be transfused for the therapy of a subject, wherein said method comprises the steps of the method of claim 1 and the further step (d) of selecting the amount of said cells to be transfused for the therapy of a subject based on the result obtained in step (c). 8. A method for selecting a suitable amount of a hematopoietic growth factor or cytokine for the treatment of a subject, wherein said method comprises the steps of the method of claim 1 and the further step(d) selecting a suitable amount of a hematopoietic growth factor or cytokine for the treatment of said subject based on the result obtained in step (c). 9. The method of claim 1, wherein said subject is a human. 10. The method of claim 1, wherein said cytotoxic therapy comprises high-dose chemotherapy. 11. The method or composition of claim 10, wherein said high-dose chemotherapy comprises administration of melphalan, busulfan, cyclophosphamide, carmustine, etoposide, or cytarabine. 12. The method of claim 1, wherein said cytotoxic therapy comprises myelosupressive chemotherapy. 13. The method or composition of claim 12, wherein said myelosupressive chemotherapy comprises the administration of cyclophosphamide, etoposide, carmustine, cytarabine, melphalan, busulfan, doxorubicin, epirubicin, paclitaxel, docetaxel, thiotepa, fludarabine, vincristine, bendamustine, cisplatin, carboplatin, daunorubicin, fluorouracil, gemcitabine, idarubicin, ifosfamide, irinotecan, methotrexate, mitoxantrone, oxaliplatin, treosulfan, vinblastine, or vinorelbine. 14. The method of claim 1, wherein said cytotoxic therapy comprises radiotherapy, or wherein said subject suffers from a primary or secondary bone marrow disease, an autoimmune disease, a hereditary disease or disorder or an infection. 15. The method of claim 1, wherein said G-CSF is filgrastim or lenograstim. 16. The method of claim 1, wherein said dose of G-CSF is selected from a range of 1 to 20 g/kg body weight of the subject. 17. The method of claim 1, wherein said dose of G-CSF is 1.0, 2.5, 5, 7.5, or 10 g/kg body weight of the subject. 18. The method of claim 1, wherein said time sufficient to allow mobilization or release of the leukocytes is in the range of 1 to 120 hours. 19. The method of claim 1, wherein said time sufficient to allow mobilization or release of the leukocytes is at least 1 hour, at least 2 hours, at least 6 hours, at least 10 hours, at least 12 hours, at least 14 hours or at least 18 hours. 20. The method of claim 1, wherein the complications are selected from fever greater than 38.degree. C. or severity and duration of neutropenia. 21. The method of claim 1, wherein the complication is fever greater than 38.degree. C. 22. The method of claim 1, wherein the complication is duration of neutropenia. 23. The method of claim 1, wherein the complication is infection. 24. The method of claim 2, wherein the fever is neutropenic fever.

Details for Patent 7,815,921

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2022-03-22
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2022-03-22