Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction

Jr Link; R. K. Burt; A. E. Traynor; W. R. Drobyski; T. Seregina; J. P. Levy; L. Gordon; S. T. Rosen; W. H. Burns; B. Camitta; J. Casper; M. Horowitz; M. Juckett; C. Lawton; D. Margolis; D. Pietryga; P. Rowlings; C. Taylor; M. Furtado; J. Stefka; S. Gupta-Burt; H. Kaiser; D. H. Vesole

doi:10.1089/hum.1998.9.1-115

Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction

Jr Link, R. K. Burt, A. E. Traynor, W. R. Drobyski, T. Seregina, J. P. Levy, L. Gordon, S. T. Rosen, W. H. Burns, B. Camitta, J. Casper, M. Horowitz, M. Juckett, C. Lawton, D. Margolis, D. Pietryga, P. Rowlings, C. Taylor, M. Furtado, J. StefkaS. Gupta-Burt, H. Kaiser, D. H. Vesole

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Abstract

Title: Adoptive Immunotherapy for Relapsed Leukemia: Donor Lymphocytes Transduced with the Herpes Simplex Thymidine Kinase Gene for Remission Induction. Primary Objective: To determine the safety of administration of Herpes simplex thymidine kinase transduced donor lymphocytes after allogeneic bone marrow transplantation (BMT) for relapsed hematologic malignancies. Secondary Objective: To determine the toxicity and efficacy associated with the administration of ganciclovir to prevent graft versus host disease (GvHD) induced by the donor lymphocytes. Population: Patients ≤ 2 years of age with relapsed hematologic malignancies after allogeneic BMT. Sample Size: Forty patients. Treatment Dosage: HStk gene modified donor lymphocytes will be administered at either 0.1-2.5 x 10⁸ T cells/kg in recipients of HLA-identical sibling grafts or 0.01-1.0 x 10⁸ T cells/kg in recipients of HLA-mismatched related or HLA-unrelated marrow grafts. GvHD which is progressive or unresponsive to conventional therapy (i.e., steroids with or without cyclosporine) after 72 hours will be treated with ganciclovir given by IV infusion over 1 hour, 5 mg/kg b.i.d. for up to 21 days. Endpoints: Safety and toxicity of donor lymphocyte infusions. Efficacy endpoints: Malignancy remission induction, duration and survival, remission of GvHD.

Original language	English (US)
Pages (from-to)	115-134
Number of pages	20
Journal	Human gene therapy
Volume	9
Issue number	1
DOIs	https://doi.org/10.1089/hum.1998.9.1-115
State	Published - Jan 1 1998
Externally published	Yes

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Link, J., Burt, R. K., Traynor, A. E., Drobyski, W. R., Seregina, T., Levy, J. P., Gordon, L., Rosen, S. T., Burns, W. H., Camitta, B., Casper, J., Horowitz, M., Juckett, M., Lawton, C., Margolis, D., Pietryga, D., Rowlings, P., Taylor, C., Furtado, M., ... Vesole, D. H. (1998). Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction. Human gene therapy, 9(1), 115-134. https://doi.org/10.1089/hum.1998.9.1-115

Link, J, Burt, RK, Traynor, AE, Drobyski, WR, Seregina, T, Levy, JP, Gordon, L, Rosen, ST, Burns, WH, Camitta, B, Casper, J, Horowitz, M, Juckett, M, Lawton, C, Margolis, D, Pietryga, D, Rowlings, P, Taylor, C, Furtado, M, Stefka, J, Gupta-Burt, S, Kaiser, H & Vesole, DH 1998, 'Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction', Human gene therapy, vol. 9, no. 1, pp. 115-134. https://doi.org/10.1089/hum.1998.9.1-115

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title = "Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction",

abstract = "Title: Adoptive Immunotherapy for Relapsed Leukemia: Donor Lymphocytes Transduced with the Herpes Simplex Thymidine Kinase Gene for Remission Induction. Primary Objective: To determine the safety of administration of Herpes simplex thymidine kinase transduced donor lymphocytes after allogeneic bone marrow transplantation (BMT) for relapsed hematologic malignancies. Secondary Objective: To determine the toxicity and efficacy associated with the administration of ganciclovir to prevent graft versus host disease (GvHD) induced by the donor lymphocytes. Population: Patients ≤ 2 years of age with relapsed hematologic malignancies after allogeneic BMT. Sample Size: Forty patients. Treatment Dosage: HStk gene modified donor lymphocytes will be administered at either 0.1-2.5 x 108 T cells/kg in recipients of HLA-identical sibling grafts or 0.01-1.0 x 108 T cells/kg in recipients of HLA-mismatched related or HLA-unrelated marrow grafts. GvHD which is progressive or unresponsive to conventional therapy (i.e., steroids with or without cyclosporine) after 72 hours will be treated with ganciclovir given by IV infusion over 1 hour, 5 mg/kg b.i.d. for up to 21 days. Endpoints: Safety and toxicity of donor lymphocyte infusions. Efficacy endpoints: Malignancy remission induction, duration and survival, remission of GvHD.",

author = "Jr Link and Burt, {R. K.} and Traynor, {A. E.} and Drobyski, {W. R.} and T. Seregina and Levy, {J. P.} and L. Gordon and Rosen, {S. T.} and Burns, {W. H.} and B. Camitta and J. Casper and M. Horowitz and M. Juckett and C. Lawton and D. Margolis and D. Pietryga and P. Rowlings and C. Taylor and M. Furtado and J. Stefka and S. Gupta-Burt and H. Kaiser and Vesole, {D. H.}",

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T1 - Adoptive immunotherapy for leukemia

T2 - Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction

AU - Link, Jr

AU - Burt, R. K.

AU - Traynor, A. E.

AU - Drobyski, W. R.

AU - Seregina, T.

AU - Levy, J. P.

AU - Gordon, L.

AU - Rosen, S. T.

AU - Burns, W. H.

AU - Camitta, B.

AU - Casper, J.

AU - Horowitz, M.

AU - Juckett, M.

AU - Lawton, C.

AU - Margolis, D.

AU - Pietryga, D.

AU - Rowlings, P.

AU - Taylor, C.

AU - Furtado, M.

AU - Stefka, J.

AU - Gupta-Burt, S.

AU - Kaiser, H.

AU - Vesole, D. H.

PY - 1998/1/1

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N2 - Title: Adoptive Immunotherapy for Relapsed Leukemia: Donor Lymphocytes Transduced with the Herpes Simplex Thymidine Kinase Gene for Remission Induction. Primary Objective: To determine the safety of administration of Herpes simplex thymidine kinase transduced donor lymphocytes after allogeneic bone marrow transplantation (BMT) for relapsed hematologic malignancies. Secondary Objective: To determine the toxicity and efficacy associated with the administration of ganciclovir to prevent graft versus host disease (GvHD) induced by the donor lymphocytes. Population: Patients ≤ 2 years of age with relapsed hematologic malignancies after allogeneic BMT. Sample Size: Forty patients. Treatment Dosage: HStk gene modified donor lymphocytes will be administered at either 0.1-2.5 x 108 T cells/kg in recipients of HLA-identical sibling grafts or 0.01-1.0 x 108 T cells/kg in recipients of HLA-mismatched related or HLA-unrelated marrow grafts. GvHD which is progressive or unresponsive to conventional therapy (i.e., steroids with or without cyclosporine) after 72 hours will be treated with ganciclovir given by IV infusion over 1 hour, 5 mg/kg b.i.d. for up to 21 days. Endpoints: Safety and toxicity of donor lymphocyte infusions. Efficacy endpoints: Malignancy remission induction, duration and survival, remission of GvHD.

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Adoptive immunotherapy for leukemia: Donor lymphocytes transduced with the herpes simplex thymidine kinase gene for remission induction

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