A phase I clinical study of a serological test for detection of leukemia-associated antigens (LAA)

Marilyn S. Pollack; Joseph E. Sokal; Yashar Hirshaut; Elias Cohen; Carl Feit; Michael Gimbol; John E. Fitzpatrick

doi:10.1016/0145-2126(78)90014-0

A phase I clinical study of a serological test for detection of leukemia-associated antigens (LAA)

Marilyn S. Pollack, Joseph E. Sokal, Yashar Hirshaut, Elias Cohen, Carl Feit, Michael Gimbol, John E. Fitzpatrick

Research output: Contribution to journal › Article › peer-review

Abstract

A series of antisera to leukemia-associated antigens (LAA) were prepared by immunization of monkeys and rabbits with leukemia cells or leukemia cell extracts and absorption of the resultant antisera with red blood cells and leukocytes from healthy donors. These antisera were used with a complement-dependent microcytotoxicity test procedure at two leukemia treatment centers in a controlled Phase I clinical study designed to evaluate the specificity and sensitivity of the antisera for the detection of LAA and the suitability of the test procedure for routine clinical use. Tests of mononuclear cells prepared from coded blood samples of patients with different types of leukemia in various stages, patients with other malignancies and benign disorders unrelated to leukemia, and healthy controls indicated that several antisera had sufficient specificity and sensitivity for the detection of LAA to be of potential clinical value. These studies also suggested that such antisera might be useful in monitoring patients with leukemia and evaluating the quality of disease control, although the test procedure had some disadvantages for routine use in a general hematology laboratory.

Original language	English
Pages (from-to)	279-286
Number of pages	8
Journal	Leukemia Research
Volume	2
Issue number	4
DOIs	https://doi.org/10.1016/0145-2126(78)90014-0
State	Published - 1978
Externally published	Yes

Keywords

Leukemia-associated antigens
blastic crisis
cytotoxicity test
leukemia

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10.1016/0145-2126(78)90014-0

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title = "A phase I clinical study of a serological test for detection of leukemia-associated antigens (LAA)",

abstract = "A series of antisera to leukemia-associated antigens (LAA) were prepared by immunization of monkeys and rabbits with leukemia cells or leukemia cell extracts and absorption of the resultant antisera with red blood cells and leukocytes from healthy donors. These antisera were used with a complement-dependent microcytotoxicity test procedure at two leukemia treatment centers in a controlled Phase I clinical study designed to evaluate the specificity and sensitivity of the antisera for the detection of LAA and the suitability of the test procedure for routine clinical use. Tests of mononuclear cells prepared from coded blood samples of patients with different types of leukemia in various stages, patients with other malignancies and benign disorders unrelated to leukemia, and healthy controls indicated that several antisera had sufficient specificity and sensitivity for the detection of LAA to be of potential clinical value. These studies also suggested that such antisera might be useful in monitoring patients with leukemia and evaluating the quality of disease control, although the test procedure had some disadvantages for routine use in a general hematology laboratory.",

keywords = "Leukemia-associated antigens, blastic crisis, cytotoxicity test, leukemia",

author = "Pollack, {Marilyn S.} and Sokal, {Joseph E.} and Yashar Hirshaut and Elias Cohen and Carl Feit and Michael Gimbol and Fitzpatrick, {John E.}",

note = "Funding Information: The authors also wish to thank Peter Levitch, Director of Regulatory Affairs of the Ortho Diagnostics Research Institute for assistance in organizing the clinical study. Specimens and clinical data were obtained through the splendid collaboration of Drs. G. Gomez, H. Moayeri, J. Renick and E. S. Henderson (Chief) of the Department of Medicine A of the Rosw¢ll Park Memorial Institute (supported in part by grant CA-5834), Drs. D. Rosen, R. Vincent, A. Mittleman, J. Evans, J. Barlow, T. Lele, and O. Holderman of other Roswell Park Memorial Institute departments, Dr. R. Bettigole of the E. J. Meyer Hospital, Buffalo, N.Y., Dr. E. Neter of the Childrens Hospital, Buffalo, N.Y., Dr. J. T. Gentry, Buffalo Health Commissioner, William Murphy of the Erie County Health Department, and the Tumor Procurement Center of the Memorial Hospital for Cancer and Allied Diseases.",

year = "1978",

doi = "10.1016/0145-2126(78)90014-0",

language = "English",

volume = "2",

pages = "279--286",

journal = "Leukemia Research",

issn = "0145-2126",

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number = "4",

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T1 - A phase I clinical study of a serological test for detection of leukemia-associated antigens (LAA)

AU - Pollack, Marilyn S.

AU - Sokal, Joseph E.

AU - Hirshaut, Yashar

AU - Cohen, Elias

AU - Feit, Carl

AU - Gimbol, Michael

AU - Fitzpatrick, John E.

N1 - Funding Information: The authors also wish to thank Peter Levitch, Director of Regulatory Affairs of the Ortho Diagnostics Research Institute for assistance in organizing the clinical study. Specimens and clinical data were obtained through the splendid collaboration of Drs. G. Gomez, H. Moayeri, J. Renick and E. S. Henderson (Chief) of the Department of Medicine A of the Rosw¢ll Park Memorial Institute (supported in part by grant CA-5834), Drs. D. Rosen, R. Vincent, A. Mittleman, J. Evans, J. Barlow, T. Lele, and O. Holderman of other Roswell Park Memorial Institute departments, Dr. R. Bettigole of the E. J. Meyer Hospital, Buffalo, N.Y., Dr. E. Neter of the Childrens Hospital, Buffalo, N.Y., Dr. J. T. Gentry, Buffalo Health Commissioner, William Murphy of the Erie County Health Department, and the Tumor Procurement Center of the Memorial Hospital for Cancer and Allied Diseases.

PY - 1978

Y1 - 1978

N2 - A series of antisera to leukemia-associated antigens (LAA) were prepared by immunization of monkeys and rabbits with leukemia cells or leukemia cell extracts and absorption of the resultant antisera with red blood cells and leukocytes from healthy donors. These antisera were used with a complement-dependent microcytotoxicity test procedure at two leukemia treatment centers in a controlled Phase I clinical study designed to evaluate the specificity and sensitivity of the antisera for the detection of LAA and the suitability of the test procedure for routine clinical use. Tests of mononuclear cells prepared from coded blood samples of patients with different types of leukemia in various stages, patients with other malignancies and benign disorders unrelated to leukemia, and healthy controls indicated that several antisera had sufficient specificity and sensitivity for the detection of LAA to be of potential clinical value. These studies also suggested that such antisera might be useful in monitoring patients with leukemia and evaluating the quality of disease control, although the test procedure had some disadvantages for routine use in a general hematology laboratory.

AB - A series of antisera to leukemia-associated antigens (LAA) were prepared by immunization of monkeys and rabbits with leukemia cells or leukemia cell extracts and absorption of the resultant antisera with red blood cells and leukocytes from healthy donors. These antisera were used with a complement-dependent microcytotoxicity test procedure at two leukemia treatment centers in a controlled Phase I clinical study designed to evaluate the specificity and sensitivity of the antisera for the detection of LAA and the suitability of the test procedure for routine clinical use. Tests of mononuclear cells prepared from coded blood samples of patients with different types of leukemia in various stages, patients with other malignancies and benign disorders unrelated to leukemia, and healthy controls indicated that several antisera had sufficient specificity and sensitivity for the detection of LAA to be of potential clinical value. These studies also suggested that such antisera might be useful in monitoring patients with leukemia and evaluating the quality of disease control, although the test procedure had some disadvantages for routine use in a general hematology laboratory.

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KW - blastic crisis

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EP - 286

JO - Leukemia Research

JF - Leukemia Research

IS - 4

ER -

A phase I clinical study of a serological test for detection of leukemia-associated antigens (LAA)

Abstract

Keywords

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