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Article ; Online: The Cardiovascular Complications of Chimeric Antigen Receptor T Cell Therapy.

Jamal, Faizi A / Khaled, Samer K

2020 Volume 15, Issue 2, Page(s) 130–132

Abstract: Purpose of review: Chimeric antigen receptor T cell therapy is gaining clinical use in the management of B cell lymphomas. As the use of this unique treatment option increases, its associated toxicities will require recognition and treatment. In this ... ...

Abstract	Purpose of review: Chimeric antigen receptor T cell therapy is gaining clinical use in the management of B cell lymphomas. As the use of this unique treatment option increases, its associated toxicities will require recognition and treatment. In this review, we aim to discuss the cardiovascular toxicities of chimeric antigen receptor T cell therapy and our approach to their clinical management. Recent findings: Cardiotoxicity may be due to direct or indirect effects of infused chimeric antigen receptor T cells. The cytokine release syndrome has been described extensively in the literature. Studies have also reported cardiovascular dysfunction including hypotension, left ventricular dysfunction, heart failure, and cardiogenic shock in the setting of cytokine release syndrome. While there are no standardized guidelines for the treatment of cytokine release syndrome or associated cardiotoxicity, we present our current clinical practices. Further research is indicated into the pathophysiology of therapy-associated cardiac dysfunction and effective management strategies to optimize patient outcomes.
MeSH term(s)	Animals ; Cardiotoxicity ; Cardiovascular Diseases/etiology ; Cardiovascular Diseases/immunology ; Cardiovascular Diseases/physiopathology ; Cardiovascular Diseases/prevention & control ; Cardiovascular System/immunology ; Cardiovascular System/physiopathology ; Cytokine Release Syndrome/etiology ; Cytokine Release Syndrome/immunology ; Cytokine Release Syndrome/physiopathology ; Cytokine Release Syndrome/prevention & control ; Hematologic Neoplasms/immunology ; Hematologic Neoplasms/therapy ; Humans ; Immunotherapy, Adoptive/adverse effects ; Prognosis ; Receptors, Chimeric Antigen/immunology ; Risk Assessment ; Risk Factors ; T-Lymphocytes/immunology ; T-Lymphocytes/transplantation
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2020-03-12
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2229765-0
ISSN	1558-822X ; 1558-8211
ISSN (online)	1558-822X
ISSN	1558-8211
DOI	10.1007/s11899-020-00567-4
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Zs.A 6332: Show issues

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Article ; Online: Cytokine Release Syndrome With the Novel Treatments of Acute Lymphoblastic Leukemia: Pathophysiology, Prevention, and Treatment.

Aldoss, Ibrahim / Khaled, Samer K / Budde, Elizabeth / Stein, Anthony S

Current oncology reports

2019 Volume 21, Issue 1, Page(s) 4

Abstract: Purpose of review: T cell-based therapies (blinatumomab and CAR T cell therapy) have produced unprecedented responses in relapsed and refractory (r/r) acute lymphoblastic leukemia (ALL) but is accompanied with significant toxicities, of which one of the ...

Abstract	Purpose of review: T cell-based therapies (blinatumomab and CAR T cell therapy) have produced unprecedented responses in relapsed and refractory (r/r) acute lymphoblastic leukemia (ALL) but is accompanied with significant toxicities, of which one of the most common and serious is cytokine release syndrome (CRS). Here we will review the pathophysiology, prevention, and treatment of CRS. Recent findings: Efforts have been initiated to define and grade cytokine release syndrome (CRS), to identify patients at risk, to describe biomarkers that predict onset and severity, to understand the pathophysiology, and to prevent and treat severe cases to reduce T cell immunotherapy-related morbidity and mortality. Optimizing the timing of T cell-based therapies in ALL, identifying new biomarkers, and investigating novel anti-cytokine agents that have anti-CRS activity are likely to be fruitful avenues of study.
MeSH term(s)	Cytokine Release Syndrome/etiology ; Cytokine Release Syndrome/physiopathology ; Cytokine Release Syndrome/therapy ; Cytokines/metabolism ; Humans ; Immunotherapy/adverse effects ; Immunotherapy, Adoptive/adverse effects ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy
Chemical Substances	Cytokines
Language	English
Publishing date	2019-01-21
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2057359-5
ISSN	1534-6269 ; 1523-3790
ISSN (online)	1534-6269
ISSN	1523-3790
DOI	10.1007/s11912-019-0753-y
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Zs.A 5521: Show issues

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Article ; Online: Donor-derived CD19-targeted chimeric antigen receptor T cells in adult transplant recipients with relapsed/refractory acute lymphoblastic leukemia.

Aldoss, Ibrahim / Khaled, Samer K / Wang, Yan / Wang, Xiuli / Palmer, Joycelynne / Clark, Mary C / Wagner, Jamie R / Paul, Jinny / Vyas, Vibhuti / Brown, Christine E / Forman, Stephen J

Blood cancer journal

2023 Volume 13, Issue 1, Page(s) 107

MeSH term(s)	Humans ; Adult ; Receptors, Chimeric Antigen/genetics ; Transplant Recipients ; Tissue Donors ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy ; T-Lymphocytes
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2023-07-12
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural
ZDB-ID	2600560-8
ISSN	2044-5385 ; 2044-5385
ISSN (online)	2044-5385
ISSN	2044-5385
DOI	10.1038/s41408-023-00881-z
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Article ; Online: MicroRNA networks in FLT3-ITD acute myeloid leukemia.

Hoang, Dinh Hoa / Zhao, Dandan / Branciamore, Sergio / Maestrini, Davide / Rodriguez, Ivan R / Kuo, Ya-Huei / Rockne, Russell / Khaled, Samer K / Zhang, Bin / Nguyen, Le Xuan Truong / Marcucci, Guido

Proceedings of the National Academy of Sciences of the United States of America

2022 Volume 119, Issue 16, Page(s) e2112482119

Abstract: MiR-126 and miR-155 are key microRNAs (miRNAs) that regulate, respectively, hematopoietic cell quiescence and proliferation. Herein we showed that in acute myeloid leukemia (AML), the biogenesis of these two miRNAs is interconnected through a network of ... ...

Abstract	MiR-126 and miR-155 are key microRNAs (miRNAs) that regulate, respectively, hematopoietic cell quiescence and proliferation. Herein we showed that in acute myeloid leukemia (AML), the biogenesis of these two miRNAs is interconnected through a network of regulatory loops driven by the FMS-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD). In fact, FLT3-ITD induces the expression of miR-155 through a noncanonical mechanism of miRNA biogenesis that implicates cytoplasmic Drosha ribonuclease III (DROSHA). In turn, miR-155 down-regulates SH2-containing inositol phosphatase 1 (SHIP1), thereby increasing phosphor-protein kinase B (AKT) that in turn serine-phosphorylates, stabilizes, and activates Sprouty related EVH1 domain containing 1 (SPRED1). Activated SPRED1 inhibits the RAN/XPO5 complex and blocks the nucleus-to-cytoplasm transport of pre-miR-126, which cannot then complete the last steps of biogenesis. The net result is aberrantly low levels of mature miR-126 that allow quiescent leukemia blasts to be recruited into the cell cycle and proliferate. Thus, miR-126 down-regulation in proliferating AML blasts is downstream of FLT3-ITD–dependent miR-155 expression that initiates a complex circuit of concatenated regulatory feedback (i.e., miR-126/SPRED1, miR-155/human dead-box protein 3 [DDX3X]) and feed-forward (i.e., miR-155/SHIP1/AKT/miR-126) regulatory loops that eventually converge into an output signal for leukemic growth.
MeSH term(s)	DEAD-box RNA Helicases/metabolism ; Down-Regulation ; Humans ; Leukemia, Myeloid, Acute/genetics ; Leukemia, Myeloid, Acute/metabolism ; MicroRNAs/metabolism ; Mutation ; fms-Like Tyrosine Kinase 3/genetics ; fms-Like Tyrosine Kinase 3/metabolism
Chemical Substances	MIRN126 microRNA, human ; MIRN155 microRNA, human ; MicroRNAs ; FLT3 protein, human (EC 2.7.10.1) ; fms-Like Tyrosine Kinase 3 (EC 2.7.10.1) ; DDX3X protein, human (EC 3.6.1.-) ; DEAD-box RNA Helicases (EC 3.6.4.13)
Language	English
Publishing date	2022-04-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.2112482119
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Zs.A 1148: Show issues

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Article ; Online: Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2 Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell Transplantation-Associated Thrombotic Microangiopathy.

Khaled, Samer K / Claes, Kathleen / Goh, Yeow Tee / Kwong, Yok Lam / Leung, Nelson / Mendrek, Włodzimierz / Nakamura, Ryotaro / Sathar, Jameela / Ng, Edmund / Nangia, Narinder / Whitaker, Steve / Rambaldi, Alessandro

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2022 Volume 40, Issue 22, Page(s) 2447–2457

Abstract: Purpose: Hematopoietic stem-cell transplantation-associated thrombotic microangiopathy (HSCT-TMA) is a serious complication with significant mortality and no approved therapy. HSCT-TMA results from endothelial injury, which activates the lectin pathway ... ...

Abstract	Purpose: Hematopoietic stem-cell transplantation-associated thrombotic microangiopathy (HSCT-TMA) is a serious complication with significant mortality and no approved therapy. HSCT-TMA results from endothelial injury, which activates the lectin pathway of complement. Narsoplimab (OMS721), an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), was evaluated for safety and efficacy in adults with HSCT-TMA. Methods: In this single-arm open-label pivotal trial (NCT02222545), patients received intravenous narsoplimab once weekly for 4-8 weeks. The primary end point (response rate) required clinical improvement in two categories: (1) laboratory TMA markers (both platelet count and lactate dehydrogenase) and (2) organ function or freedom from transfusion. Patients receiving at least one dose (full analysis set [FAS]; N = 28) were analyzed. Results: The response rate was 61% in the FAS population. Similar responses were observed across all patient subgroups defined by baseline features, HSCT characteristics, and HSCT complications. Improvement in organ function occurred in 74% of patients in the FAS population. One-hundred-day survival after HSCT-TMA diagnosis was 68% and 94% in FAS population and responders, respectively, whereas median overall survival was 274 days in the FAS population. Narsoplimab was well tolerated, and adverse events were typical of this population, with no apparent safety signal of concern. Conclusion: In this study, narsoplimab treatment was safe, significantly improved laboratory TMA markers, and resulted in clinical response and favorable overall survival.
MeSH term(s)	Adult ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Biomarkers ; Hematopoietic Stem Cell Transplantation/adverse effects ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Mannose-Binding Lectin/therapeutic use ; Serine Proteases/therapeutic use ; Thrombotic Microangiopathies/chemically induced ; Thrombotic Microangiopathies/drug therapy
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Biomarkers ; Mannose-Binding Lectin ; Serine Proteases (EC 3.4.-) ; narsoplimab (FT24ZQQ5RP)
Language	English
Publishing date	2022-04-19
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.21.02389
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Zs.A 1847: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Allogeneic hematopoietic cell transplantation for acute lymphoblastic leukemia in adults.

Khaled, Samer K / Thomas, Sandra H / Forman, Stephen J

Current opinion in oncology

2012 Volume 24, Issue 2, Page(s) 182–190

Abstract: Purpose of review: Acute lymphoblastic leukemia (ALL) is a heterogeneous disease, for which treatment guidelines are still evolving. Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapeutic modality for ALL, and ... ...

Abstract	Purpose of review: Acute lymphoblastic leukemia (ALL) is a heterogeneous disease, for which treatment guidelines are still evolving. Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative therapeutic modality for ALL, and this review describes the recent studies and current practice patterns concerning the who, when, and how of allo-HCT in the management of ALL. Recent findings: Allogeneic stem cell transplantation is the treatment of choice for patients with ALL after first relapse and is also recommended for high-risk patients in first complete remission (CR1). Minimal residual disease evaluation and monitoring is developing as an important prognostic factor and could guide physicians in determining which patients, especially those with standard risk, might require transplant. Tyrosine kinase inhibitor (TKI) therapy allows a much higher proportion of Philadelphia-chromosome-positive ALL patients to attain remission and proceed to transplant with improved results; posttransplant TKI maintenance therapy may also provide survival benefit. Reduced-intensity conditioning regimens are a reasonable alternative for patients who would otherwise be ineligible for transplant because of age or comorbidity. Summary: For patients with high-risk features, there is general agreement that allo-HCT in CR1 is a potentially curative option; however, there is no consensus on early transplant for standard-risk patients.
MeSH term(s)	Acute Disease ; Antineoplastic Agents/therapeutic use ; Clinical Trials as Topic ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Myeloablative Agonists/therapeutic use ; Neoplasm, Residual ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/therapy ; Prognosis ; Protein Kinase Inhibitors/therapeutic use ; Transplantation, Homologous
Chemical Substances	Antineoplastic Agents ; Myeloablative Agonists ; Protein Kinase Inhibitors
Language	English
Publishing date	2012-01-03
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	1049384-0
ISSN	1531-703X ; 1040-8746
ISSN (online)	1531-703X
ISSN	1040-8746
DOI	10.1097/CCO.0b013e32834f5c41
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Zs.A 3046: Show issues

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Article ; Online: Favorable Activity and Safety Profile of Memory-Enriched CD19-Targeted Chimeric Antigen Receptor T-Cell Therapy in Adults with High-Risk Relapsed/Refractory ALL.

Clinical cancer research : an official journal of the American Association for Cancer Research

2022 Volume 29, Issue 4, Page(s) 742–753

Abstract: Purpose: A phase I/II study evaluating the safety and activity of memory-enriched CD19-directed chimeric antigen receptor (CD19-CAR) T cells in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).: Patients and methods: In phase ...

Abstract	Purpose: A phase I/II study evaluating the safety and activity of memory-enriched CD19-directed chimeric antigen receptor (CD19-CAR) T cells in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). Patients and methods: In phase I, we tested sequentially two cell populations for CAR transduction: (i) central memory (Tcm) or (ii) naïve, stem, and central memory (Tn/mem) T cells. The study employed an activity constrained for toxicity design to determine the recommended phase II dose (RP2D), which was tested in phase II. Results: The Tcm cohort was closed early due to lack of activity. The 200 ×106 Tn/mem-derived CD19-CAR T-cell dose was found to be safe and active, and was declared the RP2D. At RP2D, 58 participants underwent leukapheresis and 46 received CD19-CAR T cells. Median age for treated participants was 38 years (range, 22-72). Twenty-nine (63%) participants had relapsed post-allogeneic hematopoietic cell transplantation (alloHCT), 18 (39%) had Philadelphia-like (Ph-like) genotype, and 16 (35%) had extramedullary disease (EMD) at lymphodepletion (LD). Three (7%) participants had grade 3 cytokine release syndrome (CRS), and none had grade ≥ 4 CRS. Eight (17%) participants had grade ≥ 3 neurotoxicity, including one fatal cerebral edema. Forty (87%) patients achieved complete remission (CR)/CR with incomplete hematologic recovery, 2 (4%) progressed, and 4 (9%) were unevaluable for response. Among 42 response-evaluable participants, 16/17 with Ph-like ALL and 13/15 with EMD at LD responded. Twenty-one (53%) responders underwent alloHCT consolidation, which was associated with improved relapse-free survival (adjusted HR = 0.16; 95% confidence interval, 0.05-0.48; P = 0.001). Conclusions: Tn/mem-derived CD19-CAR T cells were safe and active, including in Ph-like ALL and EMD. See related commentary by El Marabti and Abdel-Wahab, p. 694.
MeSH term(s)	Humans ; Adult ; Young Adult ; Middle Aged ; Aged ; Receptors, Chimeric Antigen/genetics ; Receptors, Chimeric Antigen/therapeutic use ; Immunotherapy, Adoptive/adverse effects ; T-Lymphocytes/immunology ; Lymphoma, B-Cell/drug therapy ; Antigens, CD19/immunology ; Hematopoietic Stem Cell Transplantation
Chemical Substances	Receptors, Chimeric Antigen ; Antigens, CD19
Language	English
Publishing date	2022-10-09
Publishing country	United States
Document type	Editorial ; Research Support, N.I.H., Extramural ; Comment
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-22-2038
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Zs.A 4223: Show issues

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Article ; Online: Clinical Outcomes in Patients with FLT3-ITD-Mutated Relapsed/Refractory Acute Myelogenous Leukemia Undergoing Hematopoietic Stem Cell Transplantation after Quizartinib or Salvage Chemotherapy in the QuANTUM-R Trial.

Ganguly, Siddhartha / Cortes, Jorge E / Krämer, Alwin / Levis, Mark J / Martinelli, Giovanni / Perl, Alexander E / Russell, Nigel H / Arunachalam, Meena / Santos, Cedric Dos / Gammon, Guy / Lesegretain, Arnaud / Mires, Derek E / Pham, Hoang / Wang, Yibin / Khaled, Samer K

Transplantation and cellular therapy

2020 Volume 27, Issue 2, Page(s) 153–162

Abstract: Despite the substantial clinical activity of fms-related tyrosine kinase 3 (FLT3) inhibitors in relapsed or refractory (R/R) FLT3-ITD‒positive acute myelogenous leukemia (AML), durable remissions and prolonged survival in this population require ... ...

Abstract	Despite the substantial clinical activity of fms-related tyrosine kinase 3 (FLT3) inhibitors in relapsed or refractory (R/R) FLT3-ITD‒positive acute myelogenous leukemia (AML), durable remissions and prolonged survival in this population require allogeneic hematopoietic stem cell transplantation (allo-HSCT). Quizartinib, a once-daily oral, highly potent, and selective FLT3 inhibitor, significantly prolonged overall survival (OS) and improved clinical benefit compared with salvage chemotherapy (median OS, 6.2 months versus 4.7 months; hazard ratio [HR], .76; 95% confidence interval [CI], .58 to .98; P = .018; composite complete remission [CRc] rate, 48% versus 27%; median duration of CRc, 2.8 months versus 1.2 months; mortality rate, .8% versus 14% by day 30, 7% versus 24% by day 60) in patients with R/R FLT3-ITD AML in the phase 3 QuANTUM-R trial. In this post hoc analysis, we described the characteristics of and clinical outcomes in patients who underwent on-study HSCT in QuANTUM-R at the investigator's discretion and institutional practices. Of 367 randomized patients, 78 (32%) in the quizartinib arm and 14 (11%) in the salvage chemotherapy arm underwent on-study allo-HSCT without any intervening therapy for AML after quizartinib or study-specified salvage chemotherapy. Pooled data of patients from both treatment arms showed a longer median overall survival (OS) in transplant recipients versus those treated without allo-HSCT (12.2 months versus 4.4 months; HR, .315; 95% CI, .233 to .427). Pooled data also showed a longer median OS in patients with a last recorded response of CRc before allo-HSCT versus patients without a CRc (20.1 months versus 8.8 months; HR, .506; 95% CI, .296 to .864). By treatment arm, the median OS was 25.1 months with quizartinib and 20.1 months with salvage chemotherapy in patients with a last recorded response of CRc before allo-HSCT. Forty-eight patients in the quizartinib arm continued quizartinib treatment after allo-HSCT. In the 31 patients with a last recorded response of CRc before allo-HSCT who continued quizartinib after allo-HSCT, the median OS was 27.1 months. Continuation of quizartinib after allo-HSCT was tolerable, and no new safety signals were identified. These results suggest that post-transplantation survival following salvage chemotherapy and quizartinib treatment are similar. However, quizartinib response occurs more frequently than with salvage chemotherapy, potentially allowing more patients to undergo transplantation and achieve durable clinical benefit. In addition, post-transplant quizartinib was found to be tolerable and may be associated with prolonged survival in some patients, highlighting its potential value in the management of patients with FLT3-ITD R/R AML.
MeSH term(s)	Benzothiazoles ; Hematopoietic Stem Cell Transplantation ; Humans ; Leukemia, Myeloid, Acute/drug therapy ; Phenylurea Compounds ; fms-Like Tyrosine Kinase 3/genetics
Chemical Substances	Benzothiazoles ; Phenylurea Compounds ; quizartinib (7LA4O6Q0D3) ; FLT3 protein, human (EC 2.7.10.1) ; fms-Like Tyrosine Kinase 3 (EC 2.7.10.1)
Language	English
Publishing date	2020-10-02
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.bbmt.2020.09.036
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Zs.A 5082: Show issues

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Article ; Online: Pracinostat plus azacitidine in older patients with newly diagnosed acute myeloid leukemia: results of a phase 2 study.

Garcia-Manero, Guillermo / Abaza, Yasmin / Takahashi, Koichi / Medeiros, Bruno C / Arellano, Martha / Khaled, Samer K / Patnaik, Mrinal / Odenike, Olatoyosi / Sayar, Hamid / Tummala, Mohan / Patel, Prapti / Maness-Harris, Lori / Stuart, Robert / Traer, Elie / Karamlou, Kasra / Yacoub, Abdulraheem / Ghalie, Richard / Giorgino, Ruben / Atallah, Ehab

Blood advances

2019 Volume 3, Issue 4, Page(s) 508–518

Abstract: Pracinostat, a potent oral pan-histone deacetylase inhibitor with modest single-agent activity in acute myeloid leukemia (AML), has shown synergistic antitumor activity when combined with azacitidine. This single-group, multicenter phase 2 study assessed ...

Abstract	Pracinostat, a potent oral pan-histone deacetylase inhibitor with modest single-agent activity in acute myeloid leukemia (AML), has shown synergistic antitumor activity when combined with azacitidine. This single-group, multicenter phase 2 study assessed the safety and efficacy of pracinostat combined with azacitidine in patients who were at least 65 years old with newly diagnosed AML and who were ineligible for standard induction chemotherapy. Patients received pracinostat 60 mg/d, 3 d/wk, for 3 consecutive weeks, plus azacitidine 75 mg/m
MeSH term(s)	Aged ; Aged, 80 and over ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Azacitidine/adverse effects ; Azacitidine/therapeutic use ; Benzimidazoles/adverse effects ; Benzimidazoles/therapeutic use ; Female ; Humans ; Leukemia, Myeloid, Acute/diagnosis ; Leukemia, Myeloid, Acute/drug therapy ; Male ; Survival Analysis ; Treatment Outcome
Chemical Substances	Antineoplastic Agents ; Benzimidazoles ; SB939 compound ; Azacitidine (M801H13NRU)
Language	English
Publishing date	2019-02-15
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2018027409
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Zs.A 7153: Show issues

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Article ; Online: Influence of Absorption, Distribution, Metabolism, and Excretion Genomic Variants on Tacrolimus/Sirolimus Blood Levels and Graft-versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation.

Khaled, Samer K / Palmer, Joycelynne M / Herzog, Josef / Stiller, Tracey / Tsai, Ni-Chun / Senitzer, David / Liu, Xueli / Thomas, Sandra H / Shayani, Sepideh / Weitzel, Jeffrey / Forman, Stephen J / Nakamura, Ryotaro

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2016 Volume 22, Issue 2, Page(s) 268–276

Abstract: Allelic variants of genes implicated in drug absorption, distribution, metabolism, and excretion (ADME) determine the pharmacokinetic variability of many medications and are increasingly recognized as important factors determining the success or failure ... ...

Abstract	Allelic variants of genes implicated in drug absorption, distribution, metabolism, and excretion (ADME) determine the pharmacokinetic variability of many medications and are increasingly recognized as important factors determining the success or failure of medical treatments. Both tacrolimus and sirolimus have narrow therapeutic ranges maintained by therapeutic drug monitoring (TDM). Using an ADME panel that covers >99% of the PharmaADME working group core list (188 single nucleotide polymorphism [SNP] and 12 copy number variant [CNV] assays in 36 pharmacogenetically relevant genes), we studied 177 patients who underwent allogeneic hematopoietic cell transplantation (HCT) using tacrolimus/sirolimus-based graft-versus-host disease (GVHD) prophylaxis. We tested for possible associations between ADME variants and tacrolimus/sirolimus drug levels, concentration/dose (C/D) ratio, and clinical endpoints, including acute GVHD. A total of 62 SNP and 6 CNV assays were evaluable after removing the variants, which were homozygous in (nearly) all samples. For sirolimus, rs2032582 (ABCB1) T-carriers versus non-T-carriers were associated with higher blood levels (P = .01), with similar results for C/D ratio. Generalized estimating equation analysis supported these findings. For tacrolimus, rs776746 CYP3A53/3 and CYP3A53/1 were associated with higher blood levels than CYP3A51/1 (P = .002). By multivariable analysis, rs776746 CYP3A53/3 and CYP3A53/1 were independently associated with decreased acute GVHD compared with CYP3A51/1, after adjustment for conditioning, donor type, race/ethnicity, and age. We demonstrated association of specific ADME genetic polymorphisms with blood levels of tacrolimus/sirolimus, and incidence of acute GVHD after HCT, in spite of TDM and dose adjustment. A larger ongoing study will determine whether these associations have clinical utility beyond TDM.
MeSH term(s)	Adolescent ; Adult ; Aged ; Child ; Female ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/therapeutic use ; Male ; Middle Aged ; Pharmacogenetics/methods ; Sirolimus/administration & dosage ; Sirolimus/pharmacology ; Sirolimus/therapeutic use ; Tacrolimus/administration & dosage ; Tacrolimus/pharmacology ; Tacrolimus/therapeutic use ; Transplantation Conditioning/methods ; Transplantation, Homologous/methods ; Young Adult
Chemical Substances	Immunosuppressive Agents ; Sirolimus (W36ZG6FT64) ; Tacrolimus (WM0HAQ4WNM)
Language	English
Publishing date	2016-02
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2015.08.027
Database	MEDical Literature Analysis and Retrieval System OnLINE

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